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.
Check against the official notice below — it lists the full affected range.
GE Healthcare is recalling 334 Discovery XR656 wall stand radiographic systems (162 in the US and 172 outside the US) distributed across multiple states and countries including the United States, Canada, Argentina, Australia, Japan, and many others. The recall addresses a potential safety issue involving nylon hooks that support the FlashPad detector on these systems. Reported incidents of detector falls have occurred, although no injuries have been reported to date.
The source does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. 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 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 AR Quantity: 334 (162 US, 172 OUS). Lot/code info: 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 630208DR4 00000101258HL2 314768SMRM5 00000101259HL0 303GVA656RM1 00000101260HL8 949517RM3 00000101261HL6 239HPCXR1 00000101881HL1 708226XR656B 00000101882HL9 313745ER656 00000101883HL7 504349R4 00000102301HL9 804764ER2 00000102304HL3 225658DR2 00000102305HL0 509946XR656A 00000102306HL8 303GVA656RM2 00000102307HL6 248305D656RM2 00000102575HL8 770385DR1 00000102576HL6 830RHHRAD1 00000102851HL3 757736PWR1 00000102852HL1 914MSK656 00000102853HL9 504349POB1 00000103439HL6 303DHXR656 00000103441HL2 910417XR656 00000103669HL8 312996D656 00
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.