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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2291-2014

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.

Publicado el 27 de agosto de 2014 · Inicio del retiro: 25 de julio de 2014

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
GE Healthcare, LLC
Distribuidor
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.
Lote
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 00000103671HL4 801714RM2DR 00000103672HL2 504842IMR2 00000103959HL3 304429DIS656 00000103961HL9 701234XR656 00000104239HL9 979SJRHCRAD 00000104241HL5 517841XR656 00000104242HL3 808QMCER 00000104243HL1 713792XR3656 00000104709HL1 850505NH656 00000104711HL7 816234COPC2 00000104712HL5 XR249643 00000104713HL3 770382CER 00000104714HL1 406731MXR1 00000105160HL6 713792XR3656 00000105161HL4 419291DR2 00000105162HL2 414649XR656 00000105163HL0 314633SW 00000105165HL5 720UCHAOP2 00000105503HL7 MHXRAY1 00000105506HL0 713792XR4656 00000105507HL8 717791D656 00000106114HL2 516719ERDIG 00000106120HL9 757736RM4 00000106123HL3 936SLW656RM2 00000106124HL1 MHXRAY2 00000106673HL7 310680RM3 00000106674HL5 865541EDXR 00000106677HL8 217383EDXR2 00000106678HL6 269966XR656B 00000106968HL1 763795XR1 00000106970HL7 608258656D2 00000106974HL9 913345MDR1 00000106975HL6 808QMCRM2 00000106976HL4 830RHHRAD4 00000107176HL0 608258656D1 00000107177HL8 912920HXR656 00000107381HL6 314525656RM4 00000107383HL2 719VAMC123 00000107386HL5 217383EDXR1 00000107816HL1 915595XR656 00000107818HL7 734439XR656MAIN 00000107820HL3 412664R18 00000107821HL1 NYPAL222 00000108130HL6 DUKEURO656 00000108133HL0 815547D656 00000108134HL8 GWNT656XR1 00000108136HL3 646888XR656C 00000108703HL0 504842ORTH2 00000108709HL7 630208DER656 00000108714HL7 361694DR1 00000108722HL0 281METHSPXR 00000109569HL4 585922WILRADDR1 00000109570HL2 847570DR4 00000109987HL8 505UNMH656 00000110168HL2 646888XR656A 00000110173HL2 504873TR3D 00000110174HL0 646888XR656B 00000110428HL0 936SLW656RM1 00000110869HL5 908232D656 00000110870HL3 386FHD656 00000110877HL8 419529D656 00000103954HL4 707SSRD656 00000103956HL9 816234COPC3 00000104706HL7 254SWCHRAD1 00000105501HL1 269966XR656A 00000106125HL8 217379PXR1 00000107376HL6 828298S 00000107812HL0 757953ORTH2 00000107813HL8 313576D656B 00000108693HL3 518243ER1 00000108696HL6 4164522 00000107388HL1 GON:4180565 00000108131HL4 GON:4191836 00000108411HL0 716821OPRM2 00000108705HL5 217586G656 00000108708HL9 GON:4212438 00000108721HL2 530332XR656TR 00000109567HL8 530332XR656 00000110167HL4 GON:4180557 00000110169HL0 719VAMC124 00000110170HL8 716821OPRM1 00000110175HL7 719VAMC125 00000110432HL2 530244XR656 00000110879HL4 706544XR 00000103667HL2 217784GXR 00000105158HL0 510HCPXR656 00000105159HL8 GON: 4046606 00000107374HL1 713792FP1XR4656 00000107378HL2 707432DR3 0
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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