Recall Z-0550-2025 ยท KPR System, X-Ray, Stationary
GE Healthcare (China) Co., Ltd.
GE Proteus XR/A radiographic system
| Date | Nov 25, 2024 (initiated Oct 24, 2024) |
| Status | Open, Classified |
| Reason | Steel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have not been replaced at the intervals detailed in the Preventative Maintenance Action List. |
| Root cause | Equipment maintenance |
| Action | An URGENT MEDICAL DEVICE CORRECTION notification letter dated 10/24/24 was sent to customers. Actions to be taken by Customer/User " You can continue to use the system for table exams without limitations. " You can continue to use the wall stand for exams where the patient does not have any part of their body underneath the bucky. " Do not perform exams where the patient has any body part underneath the bucky until the Wall Stand steel cable has been inspected and if necessary, has been replaced. Please ensure all potential users in your facility are made aware of this safety notification an |
| Quantity | 956 systems |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993090 | SILHOUETTE FC Ge Medical Systems, Inc., Oct 1, 1999 |