The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator
FDA device recall Z-0553-2024 · posted 2023-12-14 · Open, Classified
Recall details
- Recalling firm
- GE Hangwei Medical Systems, Co. LTD
- Reason for recall
- 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.
- Action taken
- 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
- Root cause
- Process design
- Status
- Open, Classified
- Product code
- KPR
- Quantity affected
- 68 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2023-11-07
- Date posted
- 2023-12-14
- Location
- Beijing, China
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Discovery XR656 HD with VolumeRad (K191699) | Ge Hualun Medical Systems Co. , Ltd. | 2019-07-24 |