FDA Device recall Z-2291-2014
GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiographic images of the skull, spinal column, chest, a…
- FDA Device
- Class II
- terminated
- Published 2014-08-27
On 2014-08-27 the FDA classified a Class II recall of GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiographic images of the skull, spinal column, chest, a… by Ge Healthcare, citing 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 bee….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2291-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-25 |
| Published | 2014-08-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | 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 |
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
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.
Identifiers
| code_info | Mfg Lot or Serial # System ID 00000098016HL9 419291DR1 00000098927HL7 954MCHM656 00000099011HL9 513MWDR2 0000009901…Mfg Lot or Serial # System ID 00000098016HL9 419291DR1 00000098927HL7 954MCHM656 00000099011HL9 513MWDR2 00000099012HL7 419PERRYDR 00000099013HL5 252962ED1 00000099016HL8 419435DR 00000099440HL0 417347DPORT1 00000099441HL8 708684RAD3 00000099443HL4 708684RAD2 00000099444HL2 732840ER1 00000099445HL9 504349R8 00000099447HL5 608775XR6561 00000099448HL3 408259RMCED1 00000099846HL8 239424XR656 00000099848HL4 HSSE3D656 00000099850HL0 732840ER2 00000099851HL8 7737021555 00000100228HL6 802775RAD5 00000100230HL2 440816D656 00000100231HL0 910WAROBINSON2 00000100366HL4 334793SXR656 00000100368HL0 608775XR6563 00000100369HL8 509838RM1 00000100653HL5 303GVA656RM3 00000100654HL3 225658DR1 00000100655HL0 718240UCD 00000100658HL4 802775RAD1 00000100659HL2 610902XR656 00000101139HL4 843847TR3 00000101140HL2 765747XR656 00000101251HL7 724357ED1 00000101252HL5 281METHP656 00000101253HL3 206598UWEAST 00000101255HL8 919731XR656 00000101256HL6 518943D656 00000101257HL4 63 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2291-2014%22
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