GE Healthcare — Class II medical device recall Z-2291-2014
Terminated recall by GE Healthcare, LLC, reported 2014-08-27, distributed in AL, CA, CO, FL, GA, HI, IL, IN…. GE Healthcare has become aware of a potential safety issue involving the nylon hooks which support the FlashPa
| Recall number | Z-2291-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2014-07-25 |
| Classified | 2014-08-20 |
| Reported by FDA | 2014-08-27 |
| Terminated | 2015-02-20 |
| Distributed | AL, CA, CO, FL, GA, HI, IL, IN, KS, LA, MD, MI, MN, MO, MT, NC, NJ, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV |
| Countries outside the US | AE, AR, AT, AU, BE, BM, CA, CL, CN, DE, DK, ES, FI, FR, GB, HU, IN, IT, JP, KR, KW, MA, NO, NZ, PK, RU, SA, SE, SI, TH, UY |
| UPC / GTIN / UDI-DI | 00082407070183, 00082407130283, 83007000033413 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2291-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.