FDAFDA · Alimentos y medicamentos·N.º oficial Z-0954-2015
GE Healthcare, Proteus XR/a with wall stand model number 600-0301.
Publicado el 21 de enero de 2015 · Inicio del retiro: 8 de diciembre 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 recently become aware of a potential safety issue involving the breakage of the two steel cables which support the bucky device in the wall stand of Proteus XR/a X-ray imaging systems. No injuries reported.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- GE Healthcare
- Distribuidor
- USA: All states in continental US including, Guam, DC. OUS; ARAB EMIRATES, AUSTRIA, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, ECUADOR, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HONDURAS, HONG KONG, HUNGARY, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, KAZAKHSTAN, KUWAIT, LATVIA, LITHUANIA, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PHILIPPINES, POLAND, POLYNESIA, PORTUGAL, RUSSIAN FEDERATION, SAUDI ARABIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, UKRAINE, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM.
- Lote
- FMI 17107 - Proteus Wall Stand Counterpoise Cables Break Serial # System ID 00000044028HL9 928656ER 00000063303HL2 719595ORTHO 00000045940HL4 803751PR2 00000041478HL9 812238FPCRAD 00000057994HL6 208359PROT 00000046527HL8 310732TIPRO 00000047064HL1 318255PRO 00000036130HL3 319352PROT 00000053610HL2 336765WFBIRAD 00000021190HL4 360457ORTHO 00000037481HL9 405377PRO 00000031767HL7 406638CATOMO 00000034159HL4 407628PRO 00000031902HL0 409938TC1 00000074625HL5 419578RAD2 00000096491HL6 419636RAD 00000096684HL6 435563RAD 00000041757HL6 435586PROT 00000057200HL8 435658RAD 00000088306HL6 505983ORTHPROT 00000020347HL1 508698NEPATS 00000049345HL2 573882NSCRAD1 00000064320HL5 601788RAD1 00000048917HL9 601968MAERM1 00000016587HL8 602285PROT2 00000106226HL4 608366PRO 00000047063HL3 616752NWPROTEUS 00000033643HL8 623327XR3 00000059646HL0 630312PROT1 00000082840HL0 630856SCPRO 00000057436HL8 702396XR1 00000102867HL9 703771PROT 00000049772HL7 703784RAD1 00000067466HL3 706641CTC 00000024904HL5 708226PROT 00000041647HL9 708226RM2 00000062869HL3 757606PRO1 00000063690HL2 770252GBJ3 00000049128HL2 801IMCXR 00000036909HL0 804594RM4 00000112434HL6 805681RAD4 00000107242HL0 805681RAD5 00000027096HL7 814833PROT 00000046048HL5 818409RAD3 00000081590HL2 870245PROT 00000041480HL5 904264PRO 00000050595HL8 904381RAD 00000068296HL3 912279CCGA 00000062303HL3 912748PROT 00000035901HL8 918352DRAD1 00000061157HL4 MCCPROT1 00000061158HL2 MCCPROT2 103733HL2 918494XRTRAUMA2 00000020349HL7 210297NCRAD 00000044647HL6 252466CPRAD1 00000060369HL6 303269RM2 00000089696HL9 402294EBPROT 00000038564HL1 520202PRO1 00000038565HL8 520202PRO2 00000073629HL8 609878PRO1 00000075649HL4 609878PRO2 00000045941HL2 816282LSPRO1 00000078007HL2 817250RAD 00000061302HL6 856341PROT 00000059336HL8 203932PROT2 00000106552HL3 412232PROT1 00000019948HL9 812256RT1 00000045545HL1 662434RM2 00000046670HL6 808KWAJPROT 00000084213HL8 412315PROT1 00000050315HL1 318368PRO 00000111660HL7 276694PRO 00000068951HL3 256486XR1 00000058725HL3 931766ER1 00000031770HL1 662779RAD1 000000000000NA 706544MA2 00000104753HL9 0004177304A 00000018751HL8 201358ER1 00000042692HL4 201418ER 00000043018HL1 201418ER 00000023401HL3 201418RAD1 00000021897HL4 201418RAD3 00000060463HL7 201894PRO1 00000060864HL6 201894PRO2 00000112815HL6 203319PROT 00000065033HL3 203466PRO 00000016999HL5 203679RAD 00000058726HL1 203688C262 00000065367HL5 203688PROT2 00000074013HL4 203688PROT2 00000063510HL2 203739PROT 00000022750HL4 203797PROT2 00000028477HL8 203852RM5 00000057596HL9 203932PROT1 00000038056HL8 217333MXR1 00000028501HL5 217337CXR3 00000081384HL0 217366CWXR2 00000021397HL5 217366CXR1 00000034089HL3 217383CXR20 00000033499HL5 217383CXR24 00000044381HL2 217431CFAXR1 00000026066HL1 217431CXR1 00000062685HL3 217443UXR2 00000024374HL1 217732LPR1 00000017462HL3 217788PRT1 00000023841HL0 217824PRT 00000065364HL2 217854RAD1 00000052078HL3 217893CRA2 00000052238HL3 218229PROT 00000016191HL9 218759RAD 00000084370HL6 218773RAD 00000080250HL4 218828RAD1 00000061264HL8 218983RAD 00000017830HL1 219284ER 00000016991HL2 219347RAD 00000017822HL8 219492RAD1 00000018607HL2 219492RAD2 00000022756HL1 219757ER 00000028879HL5 219757WP1 00000111658HL1 219836PRO2 00000028783HL9 225761R5 00000033602HL4 228436XR1 00000057198HL4 228875PRXRA 00000041103HL3 229243RAD1 00000023267HL8 229249SSC 00000074884HL8 229257MR1 00000027844HL0 229259OUT 00000083631HL2 229259PR2 00000036119HL6 229276PROT 00000021034HL4 229386TER 00000057595HL1 229434PER 00000019691HL5 229890CR4 00000018991HL0 231547PROTEUS 00000065484HL8 231726PROTEUS2 00000064530HL9 231726PROTEUS3 00000028630HL2 231924ER 00000016391HL5 231924RM3 00000028785HL4 239254RAD 00000033660HL2 239368XR1 00000049934HL3 239403RAD 00000025617HL2 239432XR1 00000022389HL1 240379RAD 00000035861HL4 248652ER 00000025565HL3 248652RAD4 00000030083HL0 248858ER1 00000017618HL0
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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