GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3) A0659MB
Reported: January 15, 2025 Initiated: November 25, 2024 #Z-0811-2025
Product Description
GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3) A0659MB
Reason for Recall
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.
Details
- Recalling Firm
- GE Medical Systems, LLC
- Units Affected
- 53 units
- Distribution
- Worldwide
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3) A0659MB. Recalled by GE Medical Systems, LLC. Units affected: 53 units.
Why was this product recalled? ▼
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 15, 2025. Severity: Moderate. Recall number: Z-0811-2025.
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