GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiographic images of the skull, spin
FDA device recall Z-2291-2014 · posted 2014-08-20 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE Healthcare has become aware of a potential safety issue involving the nylon hooks which support the FlashPad" detector on the Discovery XR656 wall stand systems. There have been reported incidents of detector falls, but no injuries have been reported.
- Action taken
- Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated July 25, 2014. The letter was addressed to Hospital Administrators / Risk Mangers, 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 the USA call 800-437-1171. For other countries contact your local GE Healthcare Representative.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- lZE
- Quantity affected
- 334 (162 US, 172 OUS).
- Distribution
- USA: AL, CA, CO, FL, GA, HI, IL, IN, KS, LA, MD,MI, MN, MO, MT, NJ, NM, NY, NC, OH, OR, PA, SC, TN, TX, UT, VT, VA, WA, WV, WI. OUS: ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BERMUDA, CANADA, CHILE CHIN
- Date initiated
- 2014-07-25
- Date posted
- 2014-08-20
- Date terminated
- 2015-02-20
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS) (K132261) | Ge Medical Systems, LLC | 2013-11-18 |