GE Healthcare…

Date

Jan. 21, 2015

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

GE Healthcare

Product

GE Healthcare, Proteus XR/a with wall stand model number 600-0301.

Reason

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.

Distribution pattern

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.

Quantity

3096 (2486 US, 610 OUS).

Codes and lots

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 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801639MI 00000059448HL1 801714XR 00000023176HL1 801774ER 00000051941HL3 801786XR 00000060982HL6 801840RM1 00000061156HL6 801840RM2 00000031152HL2 801855RM4 00000081379HL0 802775PRO 00000068442HL3 803502XR 00000013301HL5 803641ER 00000080462HL5 803641XR4 00000021498HL1 803699PR1 00000055683HL7 803713R1 00000057439HL2 803713R3 00000015955HL8 803791LR1 00000070369HL4 804254RMA 00000021898HL2 804541ER 00000024467HL3 804747DHPER 00000078170HL8 804784RAD1 00000024735HL3 805383XR1 00000089900HL5 805418XR1 00000032165HL3 805525OPXR3 00000069561HL9 805563RAD1 00000030961HL7 805648OPXR2 00000019784HL8 805648RM1 00000024370HL9 805681ORTHO 00000059447HL3 806250RAD 00000050592HL5 806647RAD 00000051286HL3 806647RAD 00000047230HL8 808257PROTRM1 00000053316HL6 808473NMCPRTRM1 00000053415HL6 808473NMCPRTRM3 00000024471HL5 808973PROT 00000051940HL5 810648PRO 00000045758HL0 810844AVANT 00000029205HL2 810985ER 00000019150HL2 812237TH2 00000048620HL9 812254ER 00000020772HL0 864459AR1 00000024660HL3 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Recall started

Dec. 8, 2014

Device type

System, X-Ray, Stationary

Root cause (FDA)

Nonconforming Material/Component

What the company told customers

Consignees were sent on 12/8/2014 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 17107, dated December 8, 2014. The letter was addressed to Hospital Administrators /Risk Managers, Managers of Radiology / Cardiology and Radiologists / Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product correction and Contact information (For questions in USA call 800-437-1171, For other countries contact your local GE Healthcare Service Representative.

Recall number

Z-0954-2015

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0954-2015. The agency record governs; check it and the company before acting.