GE Healthcare, Proteus XR/a with wall stand model number 600-0301.
FDA device recall Z-0954-2015 · posted 2015-01-12 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- GE Healthcare has recently become aware of a potential safety issue involving the breakage of the two steel cables which support the bucky device in the wall stand of Proteus XR/a X-ray imaging systems. No injuries reported.
- Action taken
- Consignees were sent on 12/8/2014 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 17107, dated December 8, 2014. The letter was addressed to Hospital Administrators /Risk Managers, Managers of Radiology / Cardiology and Radiologists / Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product correction and Contact information (For questions in USA call 800-437-1171, For other countries contact your local GE Healthcare Service Representative.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 3096 (2486 US, 610 OUS).
- Distribution
- USA: All states in continental US including, Guam, DC. OUS; ARAB EMIRATES, AUSTRIA, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, ECUA
- Date initiated
- 2014-12-08
- Date posted
- 2015-01-12
- Date terminated
- 2016-02-03
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SILHOUETTE FC (K993090) | Ge Medical Systems, Inc. | 1999-10-01 |