Official recall record
The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, (ref Z-0552-2024)
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-11-07
- Country of alert
- China
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- GE Hangwei Medical Systems, Co. LTD
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2023-11-07 · US FDA — Medical Devices
The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/
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