Recall Z-1055-2023
GE Medical Systems Israel, Functional Imaging · initiated December 19, 2022
Class I – dangerous or defective products that could cause serious health problems or death
Product
GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 inch DHP BJG NR, b) BRIVO 615 3/8 inch, c) BRIVO B615 3/8 inch DHP BJG NR, d) B615 with new rotor, e) BRIVO B615 3/8 inch BJG, f) BRIVO B615 3/8 inch DHP BJG NR, g) B615 with new rotor; Emission Computed Tomography System
Codes / lots: a) BRIVO B615 3/8 inch DHP BJG NR: Catalog number 5376204-16, UDI/DI Not Applicable, Serial Numbers: NT2QG1900001BH; b) BRIVO 615 3/8 inch: Catalog number 5376204-16, UDI/DI To be provided, Serial Numbers: NT2QG2000002BH; c) BRIVO B615 3/8 inch DHP BJG NR: Catalog number 5376204-16, UDI/DI Not Applicable, Serial Numbers: NT2QG2000001BH; d) B615 with new rotor: Catalog number 5376204-16, UDI/DI To be provided, Serial Numbers: NT2QG1900002BH; e) BRIVO B615 3/8 inch BJG: Catalog number 5376204-16, UDI/DI Not Applicable, Serial Numbers: NT2QG1800001BH; f) BRIVO B615 3/8 inch DHP BJG NR: Catalog number H2402MP, UDI/DI To be provided, Serial Numbers: 00000168527HL0; g) B615 with new rotor: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT2QG2000003BH;
Reason for recall
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
FDA-determined cause: Process control
Action taken
GE Healthcare issue an URGENT MEDICAL DEVICE CORRECTION on 12/19/2022 by mail. The notice explained the issue and the risk, and requested the following action by taken: .GE Healthcare asks that you STOP USE of your Nuclear Medicine system, if your system is listed in the Affected Product Details and Appendix of this letter, until an inspection of your system is completed by GE Healthcare and you have been provided with a letter indicating the system can be returned to clinical use. .GE Healthcare will correct all affected products at no cost to you. GE Healthcare will inspect your system to ensure that the appropriate mitigation is correctly implemented to address this potential life-threatening concern. A GE Healthcare representative will contact you to arrange for this correction. .If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Details
- Recall number
- Z-1055-2023
- Initiated
- December 19, 2022
- Posted by FDA
- February 8, 2023
- Product code
- KPS – System, Tomography, Computed, Emission
- Quantity
- 7 units
- Distribution
- Worldwide distribution. US nationwide including Puerto Rico, Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, El Salvador, Ethiopia, Finland, France, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan…
- Recalling firm
- GE Medical Systems Israel, Functional Imaging, Tirat Carmel
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1053-2023 Class I | GE Nuclear Medicine 600/800 series systems, specifically: a) 870, b) 870 DR 3/8 inch NM…A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to… | 12/19/2022Open, Classified |
| Z-1054-2023 Class I | GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 / Dismount, c)…A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to… | 12/19/2022Open, Classified |
| Z-1056-2023 Class I | GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3/8 inch NR…A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to… | 12/19/2022Open, Classified |
| Z-1057-2023 Class I | GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry…A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to… | 12/19/2022Open, Classified |
| Z-1058-2023 Class I | GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / Dismount, c)…A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to… | 12/19/2022Open, Classified |