GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities and other body parts in patients of all ages.
FDA Recall Z-2291-2014 · Posted 2014-08-20
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Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodelZE
Date Initiated2014-07-25
Date Terminated2015-02-20
Product Quantity334 (162 US, 172 OUS).
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.
Firm Action
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
Distribution Pattern
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 CHINA, DENMARK, FINLAND, FRANCE, GERMANY, HUNGARY, INDIA, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, MOROCCO, NEW ZEALAND, NORWAY, PAKISTAN, RUSSIA, SAUDI ARABIA, SLOVENIA, SPAIN, SWEDEN,THAILAND, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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