Recall Z-0552-2024 ยท KPR System, X-Ray, Stationary
GE Hangwei Medical Systems, Co. LTD
The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The list of detectors verified and validated for use with the Discovery XR656 HD system, including their specifications, are provided in the user documentation. The System generates diagnostic The compo
| Date | Dec 14, 2023 (initiated Nov 7, 2023) |
| Status | Open, Classified |
| Reason | GE HealthCare has become aware of the potential that incorrect torque has been applied to certain bolts of the Definium Tempo and Definium Tempo Pro products which may result in a potential fall of elements of the Overhead Tube Suspension (OTS) assembly. |
| Root cause | Process design |
| Action | GE HealthCare issued an URGENT MEDICAL DEVICE CORRECTION to its consignees on 11/07/2023 via FedEx. The notice explained the issue, hazard, and recommended the use of alternative device for patient exams until a service appointment can be scheduled to address the issue. Questions or concerns: Contact 1-800-467-1171 or local Service Representative |
| Quantity | 134 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191699 | Discovery XR656 HD with VolumeRad Ge Hualun Medical Systems Co. , Ltd., Jul 24, 2019 |