Open, ClassifiedPosted Jan 10, 2025·Initiated Dec 19, 2024
8MM,LONG TIP FORCEPS,IS4000 REF 471048
Reason: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Root cause: Process change control
Recalling firm: Intuitive Surgical, Inc.Type: System, Surgical, Computer Controlled InstrumentDistribution: U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico.
O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and VietnamRecall #Z-0872-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Dec 19, 2024
8MM,CADIERE FORCEPS,IS4000 REF 471049
Reason: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Root cause: Process change control
Recalling firm: Intuitive Surgical, Inc.Type: System, Surgical, Computer Controlled InstrumentDistribution: U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico.
O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and VietnamRecall #Z-0873-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Dec 19, 2024
8MM,PROGRASP FORCEPS,IS4000 REF 471093
Reason: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Root cause: Process change control
Recalling firm: Intuitive Surgical, Inc.Type: System, Surgical, Computer Controlled InstrumentDistribution: U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico.
O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and VietnamRecall #Z-0874-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Dec 19, 2024
8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171
Reason: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Root cause: Process change control
Recalling firm: Intuitive Surgical, Inc.Type: System, Surgical, Computer Controlled InstrumentDistribution: U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico.
O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and VietnamRecall #Z-0875-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Dec 19, 2024
8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172
Reason: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Root cause: Process change control
Recalling firm: Intuitive Surgical, Inc.Type: System, Surgical, Computer Controlled InstrumentDistribution: U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico.
O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and VietnamRecall #Z-0876-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Dec 19, 2024
8MM,COBRA GRASPER,IS4000 REF 471190
Reason: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Root cause: Process change control
Recalling firm: Intuitive Surgical, Inc.Type: System, Surgical, Computer Controlled InstrumentDistribution: U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico.
O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and VietnamRecall #Z-0877-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Dec 19, 2024
8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205
Reason: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Root cause: Process change control
Recalling firm: Intuitive Surgical, Inc.Type: System, Surgical, Computer Controlled InstrumentDistribution: U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico.
O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and VietnamRecall #Z-0878-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Dec 19, 2024
8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296
Reason: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Root cause: Process change control
Recalling firm: Intuitive Surgical, Inc.Type: System, Surgical, Computer Controlled InstrumentDistribution: U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico.
O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and VietnamRecall #Z-0879-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Dec 19, 2024
8MM,MEGA SUTURECUT ND,IS4000 REF 471309
Reason: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Root cause: Process change control
Recalling firm: Intuitive Surgical, Inc.Type: System, Surgical, Computer Controlled InstrumentDistribution: U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico.
O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and VietnamRecall #Z-0880-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Dec 19, 2024
8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344
Reason: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Root cause: Process change control
Recalling firm: Intuitive Surgical, Inc.Type: System, Surgical, Computer Controlled InstrumentDistribution: U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico.
O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and VietnamRecall #Z-0881-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Dec 19, 2024
8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400
Reason: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Root cause: Process change control
Recalling firm: Intuitive Surgical, Inc.Type: System, Surgical, Computer Controlled InstrumentDistribution: U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico.
O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and VietnamRecall #Z-0882-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Dec 19, 2024
8MM,FORCE BIPOLAR,IS4000 REF 471405
Reason: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Root cause: Process change control
Recalling firm: Intuitive Surgical, Inc.Type: System, Surgical, Computer Controlled InstrumentDistribution: U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico.
O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and VietnamRecall #Z-0883-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Dec 18, 2024
GE Healthcare Infinia I, Model/Catalog Numbers:
1) 5178728,
2) H3000WE,
3) H3000WM,
4) H3000YG; System, Tomography, Computed, Emission
Reason: GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Root cause: Package design/selection
Recalling firm: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGType: System, Tomography, Computed, EmissionDistribution: WorldwideRecall #Z-0888-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Dec 18, 2024
GE Healthcare Brivo NM 615, Model/Catalog Numbers:
1) 5376204-15,
2) H2401MA,
3) H3100TA; System, Tomography, Computed, Emission
Reason: GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Root cause: Package design/selection
Recalling firm: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGType: System, Tomography, Computed, EmissionDistribution: WorldwideRecall #Z-0889-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Dec 18, 2024
GE Healthcare Discovery NM 630, Model/Catalog Numbers:
1) 5376204-30-2,
2) H2401CF,
3) H2401CH,
4) H2401JE,
5) H3100JY; System, Tomography, Computed, Emission
Reason: GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Root cause: Package design/selection
Recalling firm: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGType: System, Tomography, Computed, EmissionDistribution: WorldwideRecall #Z-0890-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Dec 18, 2024
GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers:
1) 5376204-70-54-2,
2) H2401BC,
3) H2401CE,
4) H2401CG,
5) H3100AG,
6) H3100JW,
7) H3100NC; System, Tomography, Computed, Emission
Reason: GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Root cause: Package design/selection
Recalling firm: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGType: System, Tomography, Computed, EmissionDistribution: WorldwideRecall #Z-0891-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Dec 18, 2024
GE Healthcare Discovery NM/CT 670 DR, Model/Catalog Numbers:
1) 5376204-70-56-2;
2) H2401AW;
3) H3100AN;
4) H3100BT;
5) H3100PX; System, Tomography, Computed, Emission
Reason: GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Root cause: Package design/selection
Recalling firm: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGType: System, Tomography, Computed, EmissionDistribution: WorldwideRecall #Z-0892-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Dec 18, 2024
GE Healthcare Discovery NM/CT 670 PRO, Model/Catalog Numbers:
1) 5376204-70-54-2;
2) H2401AK;
3) H2402AC;
4) H3100AH;
5) H3100XB; System, Tomography, Computed, Emission
Reason: GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Root cause: Package design/selection
Recalling firm: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGType: System, Tomography, Computed, EmissionDistribution: WorldwideRecall #Z-0893-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Dec 18, 2024
GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers:
1) H3100XF ; System, Tomography, Computed, Emission
Reason: GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Root cause: Package design/selection
Recalling firm: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGType: System, Tomography, Computed, EmissionDistribution: WorldwideRecall #Z-0894-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Dec 18, 2024
GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers:
1) H3906AB; System, Tomography, Computed, Emission
Reason: GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Root cause: Package design/selection
Recalling firm: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGType: System, Tomography, Computed, EmissionDistribution: WorldwideRecall #Z-0895-2025