Recall Z-2733-2024 ยท KPR System, X-Ray, Stationary
GE Healthcare (China) Co., Ltd.
GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 2373519; 5) 2379827; 6) 5729352; 7) 2259973-1; 8) 2259973-2; 9) 2259973-3; 10) 2259973-4; 11) Not Available
| Date | Aug 26, 2024 (initiated Jul 12, 2024) |
| Status | Open, Classified |
| Reason | The XR system, Proteus XR/a, does not have a de-installation manual describing process steps for de-installing the devices. De-installation instruction process steps must be followed when de-installing these devices to avoid personnel injury during de-install. |
| Root cause | Error in labeling |
| Action | GE HealthCare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 07/12/2024 by letter using a traceable means. The notice explained the issue and requested the following actions to be taken by the consumer/user: "You may continue to use the Proteus XR/a as intended for clinical use. This issue has no effect on clinical use of the equipment. If you intend to de-install your Proteus XR/a system or contract a 3rd party to de-install the system: 1. Ensure all instructions and guidance in the De-Installation Manual are followed. 2. Access the De-installation Manual from the p |
| Quantity | 3572 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993090 | SILHOUETTE FC Ge Medical Systems, Inc., Oct 1, 1999 |