Open, ClassifiedPosted Jan 21, 2025·Initiated Nov 25, 2024
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument
Product Name: Thunderbeat Front-Actuated Grip Type S
Model Number: TB-0545FCS
Catalog Number/Product Code: R5000688
Software Version: N/A
Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).
Reason: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: Instrument, Ultrasonic SurgicalDistribution: US Nationwide distribution and International: Algeria, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Belize, Benin, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Burkina Faso, Cambodia, Canada, Chile, China, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lithuania, Luxembourg, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Nepale, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Utd.Arab Emir., Vietnam, Yemen.Recall #Z-0994-2025
Open, ClassifiedPosted Jan 21, 2025·Initiated Nov 25, 2024
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument
Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S
Model Number: TB-0520FCS
Catalog Number/Product Code: N5424030
Software Version: N/A
Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).
Reason: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: Instrument, Ultrasonic SurgicalDistribution: US Nationwide distribution and International: Algeria, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Belize, Benin, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Burkina Faso, Cambodia, Canada, Chile, China, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lithuania, Luxembourg, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Nepale, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Utd.Arab Emir., Vietnam, Yemen.Recall #Z-0995-2025
Open, ClassifiedPosted Jan 21, 2025·Initiated Nov 25, 2024
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument
Product Name: THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Type S
Model Number: TB-0535FCS
Catalog Number/Product Code: N5423730
Software Version: N/A
Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).
Reason: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: Instrument, Ultrasonic SurgicalDistribution: US Nationwide distribution and International: Algeria, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Belize, Benin, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Burkina Faso, Cambodia, Canada, Chile, China, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lithuania, Luxembourg, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Nepale, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Utd.Arab Emir., Vietnam, Yemen.Recall #Z-0996-2025
Open, ClassifiedPosted Jan 21, 2025·Initiated Nov 25, 2024
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument
Product Name: THUNDERBEAT 5 mm,35 cm ,Front-actuated Grip Type S
Model Number: TB-0535FCS
Catalog Number/Product Code: N5423630
Software Version: N/A
Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).
Reason: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: Instrument, Ultrasonic SurgicalDistribution: US Nationwide distribution and International: Algeria, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Belize, Benin, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Burkina Faso, Cambodia, Canada, Chile, China, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lithuania, Luxembourg, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Nepale, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Utd.Arab Emir., Vietnam, Yemen.Recall #Z-0997-2025
Open, ClassifiedPosted Jan 21, 2025·Initiated Nov 25, 2024
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument
Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S
Model Number: TB-0545FCS
Catalog Number/Product Code: N5423330
Software Version: N/A
Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).
Reason: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: Instrument, Ultrasonic SurgicalDistribution: US Nationwide distribution and International: Algeria, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Belize, Benin, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Burkina Faso, Cambodia, Canada, Chile, China, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lithuania, Luxembourg, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Nepale, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Utd.Arab Emir., Vietnam, Yemen.Recall #Z-0998-2025
Open, ClassifiedPosted Jan 21, 2025·Initiated Nov 25, 2024
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument
Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S
Model Number: TB-0545FCS
Catalog Number/Product Code: N5423430
Software Version: N/A
Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).
Reason: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: Instrument, Ultrasonic SurgicalDistribution: US Nationwide distribution and International: Algeria, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Belize, Benin, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Burkina Faso, Cambodia, Canada, Chile, China, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lithuania, Luxembourg, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Nepale, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Utd.Arab Emir., Vietnam, Yemen.Recall #Z-0999-2025
Open, ClassifiedPosted Jan 21, 2025·Initiated Nov 25, 2024
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument
Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S
Model Number: TB-0545FCS
Catalog Number/Product Code: N5423510
Software Version: N/A
Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).
Reason: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: Instrument, Ultrasonic SurgicalDistribution: US Nationwide distribution and International: Algeria, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Belize, Benin, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Burkina Faso, Cambodia, Canada, Chile, China, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lithuania, Luxembourg, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Nepale, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Utd.Arab Emir., Vietnam, Yemen.Recall #Z-1000-2025
Open, ClassifiedPosted Jan 21, 2025·Initiated Nov 25, 2024
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument
Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S
Model Number: TB-0520FCS
Catalog Number/Product Code: N5423930
Software Version: N/A
Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).
Reason: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: Instrument, Ultrasonic SurgicalDistribution: US Nationwide distribution and International: Algeria, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Belize, Benin, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Burkina Faso, Cambodia, Canada, Chile, China, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lithuania, Luxembourg, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Nepale, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Utd.Arab Emir., Vietnam, Yemen.Recall #Z-1001-2025
Open, ClassifiedPosted Jan 21, 2025·Initiated Nov 25, 2024
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument
Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S
Model Number: TB-0520FCS
Catalog Number/Product Code: N5424110
Software Version: N/A
Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).
Reason: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: Instrument, Ultrasonic SurgicalDistribution: US Nationwide distribution and International: Algeria, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Belize, Benin, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Burkina Faso, Cambodia, Canada, Chile, China, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lithuania, Luxembourg, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Nepale, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Utd.Arab Emir., Vietnam, Yemen.Recall #Z-1002-2025
Open, ClassifiedPosted Jan 21, 2025·Initiated Nov 25, 2024
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument
Product Name: Thunderbeat, 5MM, 35CM, Front-actuated Grip Type S
Model Number: TB-0535FCS
Catalog Number/Product Code: N5423810
Software Version: N/A
Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).
Reason: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: Instrument, Ultrasonic SurgicalDistribution: US Nationwide distribution and International: Algeria, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Belize, Benin, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Burkina Faso, Cambodia, Canada, Chile, China, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lithuania, Luxembourg, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Nepale, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Utd.Arab Emir., Vietnam, Yemen.Recall #Z-1003-2025
Open, ClassifiedPosted Jan 21, 2025·Initiated Dec 19, 2024
BD PCR Cartridges used with MAX System. Model Number: 437519
Reason: Potential for signal drift in specific lots of BD PCR Cartridges.
Root cause: Under Investigation by firm
Recalling firm: Becton Dickinson & Co.Type: Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen TestDistribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Canada, South Korea, Taiwan, Australia, Singapore, Mexico, Hong Kong, India, Japan, Columbia, Brazil, Philippines, Argentina, New , Zealand, Uruguay, Chile, Trinidad and Tobago, Belgium, Vietnam, Macao.Recall #Z-1004-2025
Open, ClassifiedPosted Jan 21, 2025·Initiated Dec 19, 2024
Brand Name: VITROS
Product Name: VITROS 5600 Integrated System
Model/Catalog Number: 6802413 (New), 6802415 (Certified/Refurbished), 6904001 (China)
Software Version: version 3.8.0 or higher
Product Description: In vitro diagnostic chemistry analyzer.
FDA 3 letter product code: JJE
Component: No, not a component
Reason: The VITROS 5600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.
Root cause: Software Design Change
Recalling firm: Ortho-Clinical Diagnostics, INc.Type: Analyzer, Chemistry (Photometric, Discrete), For Clinical UseDistribution: Worldwide distribution - US Nationwide and the countries of 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-1005-2025
Open, ClassifiedPosted Jan 21, 2025·Initiated Dec 19, 2024
Brand Name: VITROS
Product Name: VITROS XT 7600 Integrated System
Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (China)
Software Version: version 3.8.0 or higher
Product Description: In vitro diagnostic chemistry analyzer.
FDA 3 letter product code: JJE
Component: No, not a component
Reason: The VITROS XT 7600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.
Root cause: Software Design Change
Recalling firm: Ortho-Clinical Diagnostics, INc.Type: Analyzer, Chemistry (Photometric, Discrete), For Clinical UseDistribution: Worldwide distribution - US Nationwide and the countries of 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-1006-2025
Open, ClassifiedPosted Jan 21, 2025·Initiated Dec 19, 2024
Brand Name: VITROS
Product Name: VITROS 3600 Immunodiagnostic System
Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished), 6904000 (China)
Software Version: version 3.8.0 or higher
Product Description: In vitro diagnostic chemistry analyzer.
FDA 3 letter product code: JJE
Component: no, not a component
Reason: The VITROS 3600 Immunodiagnostic System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.
Root cause: Software Design Change
Recalling firm: Ortho-Clinical Diagnostics, INc.Type: Analyzer, Chemistry (Photometric, Discrete), For Clinical UseDistribution: Worldwide distribution - US Nationwide and the countries of 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-1007-2025
Open, ClassifiedPosted Jan 18, 2025·Initiated Dec 19, 2024
Bodor P and C series laser cutting machines
Reason: Non-compliant laser products
Root cause: Radiation Control for Health and Safety Act
Recalling firm: Jinan Bodor Cnc Machine Co LtdType: Laser CutterDistribution: US Nationwide DistributionRecall #Z-0768-2025
Open, ClassifiedPosted Jan 17, 2025·Initiated Nov 24, 2024
Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;
Reason: Lack of 510(k) clearance.
Root cause: Device Design
Recalling firm: Adept Medical LtdType: Tube, TympanostomyDistribution: US Nationwide distribution.
International: Canada, New Zealand, Australia, Yemen, United Kingdom, Spain, Italy, Turkey, El Salvador, Malaysia, United Arab Emirates, Germany, Greece, Syria, Peru, Hong Kong, Turkey, Chile, Ireland.Recall #Z-0963-2025
Open, ClassifiedPosted Jan 17, 2025·Initiated Nov 24, 2024
Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;
Reason: Lack of 510(k) clearance.
Root cause: Device Design
Recalling firm: Adept Medical LtdType: Tube, TympanostomyDistribution: US Nationwide distribution.
International: Canada, New Zealand, Australia, Yemen, United Kingdom, Spain, Italy, Turkey, El Salvador, Malaysia, United Arab Emirates, Germany, Greece, Syria, Peru, Hong Kong, Turkey, Chile, Ireland.Recall #Z-0964-2025
Open, ClassifiedPosted Jan 17, 2025·Initiated Nov 24, 2024
Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;
Reason: Lack of 510(k) clearance.
Root cause: Device Design
Recalling firm: Adept Medical LtdType: Tube, TympanostomyDistribution: US Nationwide distribution.
International: Canada, New Zealand, Australia, Yemen, United Kingdom, Spain, Italy, Turkey, El Salvador, Malaysia, United Arab Emirates, Germany, Greece, Syria, Peru, Hong Kong, Turkey, Chile, Ireland.Recall #Z-0965-2025
Open, ClassifiedPosted Jan 17, 2025·Initiated Nov 24, 2024
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Reason: Lack of 510(k) clearance.
Root cause: Device Design
Recalling firm: Adept Medical LtdType: Tube, TympanostomyDistribution: US Nationwide distribution.
International: Canada, New Zealand, Australia, Yemen, United Kingdom, Spain, Italy, Turkey, El Salvador, Malaysia, United Arab Emirates, Germany, Greece, Syria, Peru, Hong Kong, Turkey, Chile, Ireland.Recall #Z-0966-2025
Open, ClassifiedPosted Jan 17, 2025·Initiated Nov 24, 2024
Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;
Reason: Lack of 510(k) clearance.
Root cause: Device Design
Recalling firm: Adept Medical LtdType: Tube, TympanostomyDistribution: US Nationwide distribution.
International: Canada, New Zealand, Australia, Yemen, United Kingdom, Spain, Italy, Turkey, El Salvador, Malaysia, United Arab Emirates, Germany, Greece, Syria, Peru, Hong Kong, Turkey, Chile, Ireland.Recall #Z-0967-2025