Open, ClassifiedPosted Jan 10, 2025·Initiated Dec 18, 2024
GE Healthcare Optima NM/CT 640, Model/Catalog Numbers:
1) H3100JZ; 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-0896-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Dec 18, 2024
GE Healthcare Infinia II, Model/Catalog Numbers:
1) H2799ZP;
2) H3000WT; 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-0897-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Dec 18, 2024
GE Healthcare Infinia I Hawkeye 1, Model/Catalog Numbers:
1) H3000WN;
2) H3000YM;
3) H3000YS; 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-0898-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Dec 18, 2024
GE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers:
1) H2799PP;
2) H2799PR;
3) H2799YC;
4) H2799YD;
5) H3000WC;
6) H3000WD;
7) H3000WT;
8) H3000WW;
9) H3000WY;
10) H3000WZ; 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-0899-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Dec 18, 2024
GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers:
1) ASM000085;
2) ASM001092;
3) SYS000001; 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-0900-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Dec 5, 2024
Brand Name: VITROS Chemistry Products
Product Name: VITROS Chemistry Products DGXN Slides
Model/Catalog Number: 8343386
Software Version: Not Applicable
Product Description: The VITROS DGXN Slide is a multilayered, analytical element coated on a polyester support.
Digoxin is a widely prescribed cardiac glycoside indicated in the treatment of congestive heart failure and supraventricular arrhythmias. Digoxin measurements are used to monitor patient compliance and therapy, and to diagnose potential overdose.
VITROS Chemistry Products DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.
One sales unit contains 5 cartridges. Each cartridge holds 18 slides (equivalent to one test), for 90 slides per sales unit.
Component: No, not a component
Reason: Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.
Root cause: Device Design
Recalling firm: QUIDEL ORTHOType: Enzyme Immunoassay, DigitoxinDistribution: Domestic: Nationwide Distribution
International: Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom,Recall #Z-0901-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Dec 5, 2024
Brand Name: VITROS Chemistry Products
Product Name: VITROS Chemistry Products DGXN Slides
Model/Catalog Number: 8343386
Software Version: Not Applicable
Product Description: The VITROS DGXN Slide is a multilayered, analytical element coated on a polyester support.
Digoxin is a widely prescribed cardiac glycoside indicated in the treatment of congestive heart failure and supraventricular arrhythmias. Digoxin measurements are used to monitor patient compliance and therapy, and to diagnose potential overdose.
VITROS Chemistry Products DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.
One sales unit contains 5 cartridges. Each cartridge holds 18 slides (equivalent to one test), for 90 slides per sales unit.
Component: No, not a component
Reason: Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.
Root cause: Device Design
Recalling firm: QUIDEL ORTHOType: Enzyme Immunoassay, DigitoxinDistribution: Domestic: Nationwide Distribution
International: Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom,Recall #Z-0902-2025
Open, ClassifiedPosted Jan 10, 2025·Initiated Nov 29, 2024
Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adhesive skin barrier and an adhesive pouch: ESTEEM SYN FLX WHT16/35MM PRECUT(1X10), REF: 405473;
ESTEEM SYN FLX WHT35/35MM PRECUT(1X10), REF: 405479
Reason: Ostomy skin barrier package contains a pre-cut wafer of 28mm instead of 16mm and/or 35mm
pre-cut wafers, as stated package labeling. If pre-cut wafers are too big the device cannot be used and if the pre-cut wafer is too small and the device user tries to apply, this could cause abrasion, stomal cut, and bleeding
Root cause: Process control
Recalling firm: ConvaTec, IncType: Protector, OstomyDistribution: US distribution to states of: OH, NY, ILRecall #Z-0903-2025
Open, ClassifiedPosted Jan 8, 2025·Initiated Dec 6, 2024
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Reason: Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.
Root cause: Process control
Recalling firm: Fresenius Kabi USA, LLCType: Pump, InfusionDistribution: US distribution to states of: ID, MN, NV, TX, VA, WI.Recall #Z-0763-2025
Open, ClassifiedPosted Jan 8, 2025·Initiated Nov 22, 2024
Citric Complete - Dry Citric Acid Concentrate
Model Number: DCA+225-25
Reason: The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca.
Root cause: Process control
Recalling firm: Nipro Renal Soultions USA, CorporationType: Dialysate Concentrate For Hemodialysis (Liquid Or Powder)Distribution: US distribution to states of: AZ, FL, GA, GA, IL, MI, NC, NJ, OH, TN, TX.Recall #Z-0820-2025
Open, ClassifiedPosted Jan 8, 2025·Initiated Nov 27, 2024
Brand Name: 3B Medical, Inc.
Product Name: Ultrasoft Oxygen Cannula, 12 Foot
Model / Catalog Number: O2U2012
Lot Number: 20170403
Product Description: Nasal Cannulas for use with Oxygen Concentrators
Reason: The devices were inadvertently shipped after their expiration date.
Root cause: Nonconforming Material/Component
Recalling firm: 3B Medical, Inc.Type: Catheter, Nasal, OxygenDistribution: US: Massachusetts and Arkansas
OUS: NoneRecall #Z-0828-2025
Open, ClassifiedPosted Jan 7, 2025·Initiated Oct 16, 2024
Smaxel Fractional CO2 Laser, a Class IV medical laser system.
Reason: The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.
Root cause: Radiation Control for Health and Safety Act
Recalling firm: IDS LTDType: Powered Laser Surgical Instrument With MicrobeamFractional OutputDistribution: Worldwide - US Nationwide DistributionRecall #Z-0804-2025
Open, ClassifiedPosted Jan 7, 2025·Initiated Nov 25, 2024
Xhibit Telemetry Receiver, Model 96280, with Service Manual.
Intended to provide monitoring system with patient data.
Reason: Telemetry receiver systems may experience a Windows proxy Issue causing the system to shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If a clinical event occurred during this period, staff may not detect until the system restarts; necessary clinical intervention could be delayed.
Root cause: Labeling design
Recalling firm: Spacelabs Healthcare, Inc.Type: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Distribution: US: OK, MN, IA, SC, NE, MI, NY, KY, GA, MO, MT, LA, WA, SD, CO, PA, WY, TX, ID, NJ, FL, OH, MS, OR, AK, IL, AR, KS, AL, TN, WI, VA, NM, CA, IN, RI, NV, MA, NC, ME, CT, AZ, MD, PR.
OUS: Kuwait, Australia, Canada, Roumanie, Greece, Philippines, Spain, Italy, Hong Kong, Switzerland, Panama, Taiwan, Netherlands, Malaysia, Poland, Mexico, United Kingdom, Saudi Arabia, France, Czech RepublicRecall #Z-0809-2025
Open, ClassifiedPosted Jan 7, 2025·Initiated Nov 25, 2024
Xhibit Telemetry Receiver with Software, Model 96280.
Intended to provide monitoring system with patient data.
Reason: Telemetry receivers with affected software versions may experience unsolicited system shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If a clinical event occurred during this period, staff may not detect until the system restarts and necessary clinical intervention could be delayed.
Root cause: Software change control
Recalling firm: Spacelabs Healthcare, Inc.Type: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Distribution: US: MN, TX, TN, SC, OK, NM, GA, PA, OH, IA, AL, CO, AR, FL, MO, ME, LA, IL, WA, MA, WI, OR, MS, ID, NY, KS, PR.
OUS: Canada, Taiwan, Czech Republic, France, Greece, Italy, Kuwait, Philippines, Poland.Recall #Z-0810-2025
Open, ClassifiedPosted Jan 7, 2025·Initiated Nov 25, 2024
GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers:
1) 5555000-3;
2) 5555000-4:
3) A0659MB
Reason: GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.
Root cause: Component design/selection
Recalling firm: GE Medical Systems, LLCType: System, X-Ray, MobileDistribution: WorldwideRecall #Z-0811-2025
Open, ClassifiedPosted Jan 7, 2025·Initiated Nov 25, 2024
GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers:
1) 5555000-12;
2) 5555000-5;
3) 5555000-6;
4) A0659PB;
5) to be provided
Reason: GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.
Root cause: Component design/selection
Recalling firm: GE Medical Systems, LLCType: System, X-Ray, MobileDistribution: WorldwideRecall #Z-0812-2025
Open, ClassifiedPosted Jan 7, 2025·Initiated Nov 25, 2024
GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers:
1) 5555000-27;
2) 5555000-31;
3) 5555000-33;
4) 5555000-41;
5) 5555000-47;
6) A0700DL;
7) A1700DA;
8) To be provided.
Reason: GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.
Root cause: Component design/selection
Recalling firm: GE Medical Systems, LLCType: System, X-Ray, MobileDistribution: WorldwideRecall #Z-0813-2025
Open, ClassifiedPosted Jan 7, 2025·Initiated Nov 18, 2024
Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-9610-000, 1107-9612-000, 1107-9616-000, 1107-9617-000, 2066835-001, 2069767-001, 2078800-001, 2091008-001, 2091009-001, M1098876, M1145610, M1220023, M1220854, M1221495, and M1233992
Reason: Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
Root cause: Process control
Recalling firm: GE Medical Systems, LLCType: Vaporizer, Anesthesia, Non-HeatedDistribution: US Nationwide. Global Distribution.Recall #Z-0814-2025
Open, ClassifiedPosted Jan 7, 2025·Initiated Nov 18, 2024
Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO
Reason: Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
Root cause: Process control
Recalling firm: GE Medical Systems, LLCType: Vaporizer, Anesthesia, Non-HeatedDistribution: US Nationwide. Global Distribution.Recall #Z-0815-2025
Open, ClassifiedPosted Jan 7, 2025·Initiated Nov 18, 2024
Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV
Reason: Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
Root cause: Process control
Recalling firm: GE Medical Systems, LLCType: Vaporizer, Anesthesia, Non-HeatedDistribution: US Nationwide. Global Distribution.Recall #Z-0816-2025