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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare, PET VCAR

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 Class 2 Recall
GE Healthcare, PET VCAR
see related information
Date Posted June 18, 2013
Recall Status1 Terminated on January 21, 2014
Recall Number Z-1551-2013
Recall Event ID 65229
Premarket Notification
510(K) Number
K063324 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product GE Healthcare, PET VCAR. PET VCAR application software is affected if installed on any of the following versions of the Advantage Workstation and AW Server: Advantage Workstation 4.6, Volume Share 5 enhanced  vxtl.11.3, vxtl.11.3 ext1, or vxtl.11.3 ext2 AW Server 2.0, Volume Share 5 enhanced  vxtl.11.3, vxtl.11.3 ext1, or vxtl.11.3 ext2 PET VCAR (Volume Computer Assisted Reading) is a PET/CT software package which can be used by the clinician to assist in diagnosis, staging, treatment planning and monitoring treatment response.
Code Information Mfg Lot or Serial # 00000L3A331FA4 00000L3A3318C4 0S804VCUPETAWS 00S804VCUPETAW 00000LE23E908A 00000LA707B8CD 0000S704783AWS 00000L3AB67847 000D1L3AB67847 00000LA70D61FE 0000G297117701 00000LFB44C088 00000LA70D6257 00000L2E5D97AC 00000LA704C3E7 00000L021DFE17 00000L97BF02A6 00000L3AA73A5B 00000LA70AB28E 00000L3AB4D639 00000L3AB501ED 00000L3AA80D28 00000L3AB4D6CC 00000L3AB50126 SNYPHAWSERVER2 00000X12335005 00000LAEDF9764 000S704783HDCT 0D1S704783HDCT SSENTARAPETDST 00000LB8CDB088 00000LA70CF2BD 00S681342AWONC 00000L97BD2680 0S856247PETUPS 00000L3AAD0E3F 00000L3A6AB2B5 00000L3A3D0C38 00000LA7053E64 00000LA7053E11 00000H12361003 00000H12361004 0000AD13018005 00000E12291003 00000E12291004 0000AV12212003 0000AV12212004 0000AV12213001 0000AV12213002 00000R12268002 00000R12268003 00000N12226004 00000N12226005 00000L3A330899 00000L3A87FE86 00000L3A86843C 00000L3A3305A1 00000LA713783D 00000LA712A01B 00000LA7142C7C SCT428868CN4AW 00000L3AA6F64A 00000X12335002 00000Q12328002 00000Q12328001 00000H12361005 0000AP12152002 0000AP12152001 00000L02135882 00000L0257B5A9 00000L026873C9 00000L3AB68D6E 00000L12130007 00000LA7053E56 000D1LA7053E56 00000L3AADF306 00000Q13066002 00000Y13070003 00000L026F4B0A 00000R12268005 00000L3A8FD336 00000L12130001 00000L12130002 00000L02167931 00000LA707FDCA 00000LA707FDC7 00000L02687367 00000L3A373C91 00000L020E0B5F 00000LA8CE7F5A 00000L02687172 00000L3AB1FAF2 00000L021500C2 00000Y13070001 0000AE12073008 00000H12275003 00000N12226001 00000L12130003 00000L12130004 00000L12130005 00000L12130006 00000P12319006 00000P12319004 0000AG12311002 00000L12130010 00000X12335004 00000P12319007 00000X12335003 00000Q12328003 0000AE12073003 0000AV12227003 00000H12361002 00000G12164003 00000L024087F6 00000E12291002 0000AD13018004 00000U12145004 00000U12145001 0000AP12152003 0000AP12152004 00000R12268001 00000H12275001 00000J12283001 0000AE12073005 0000AD13018002 00000LA70D6AAB 00000L2E5C60F0 00000A12147003 00000A12147004 00000X12335001 00000LE23E92C2 00000L3A55F90A 00000LA70D1128 0000AS12167001 00000Q13066001 0000G408959802 00000Q13052001 0000AG12311003 00000H12361001 0000AD13018003 00000L3AB67A7B 00000L3AB68E32 00000L3A996582 00000A12147005 00000LA704ABE1 00000L3AB68D9A 0000AE12073010 0000G402803003 00000E12291005 0000AS12167005 0000AG12311001 00000L12130009 00000L3A9C89A9 00000L3A9C89B2 00000L3A9C89C9 0000AE12073004 00000P12319001 00000P12319002 00000P12319003 0000AE12073001 0000AE12073002 0000ZB11278001 00000LA704A808 00000P12319005 00000L12130008 0000AE12073006 00000Q12328004 00000Q13052002 00000Q13052003 00000Q13052004 00000Q13052005 00000LA707B89E 000D1LA707BAEE 00000LA707BAEE 00000LA709781A 0000AE12073007 0000AE12073009 00000Q12328005 00000L12044001 00000L3AB68E2F 000D1L12044001 00000E12291001 0000AG12311004 00000P12319008 00000Y13070002 00000U12145005 00000LA7043632 00000LA7047A08 00000Y12118001 00000Y12118002 00000Y12118003 00000Y12118004 0000AP12152005 00000H12275002 00000G12164001 00000A12147002 00000LA70BC75D 00000LA70C6AD8 00000L3AB2DFC1 00000L0257B67E 00000G12164002 00000L0240850F 00000L0238B080 00000L02197799 00000L3A70A966 0000AV12212001 00000R12268004 00000U12145002 00000L026876F0 00000L3AAF17E5 00000L3AADF59C 00000L3AB68F2A 00000L3AB68DBA 00000L3AB68E89 00000L3AB68DBD 00000LA8CE7D16 00000L3AB6937A 00000L3AB6928F 0000AV12227001 0000AV12213005 0000AV12212005 00000N12226002 00000N12226003 0000AV12227002 00000G12164004 0000AD13018001 00000Q13066003 00000Q13066004 0000AV12227004 0000AV12227005 000S00139ADW06
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
GE Healthcare has recently become aware of a potential safety issue with respect to the automated PERCIST response criteria calculation applied in the PET VCAR application on Advantage Workstation or AW Server.
FDA Determined
Cause 2
DESIGN: Software Design
Action GE Healthcare sent an "Urgent Medical Device Correction" letter dated May 14, 2013, to all affected consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Customers with questions were instructed to call one of the following numbers: United Sates 800-437-1171 Japan 0120-055-919 For other countries they were instructed to contact their local GE Healthcare Service Representative. For questions regarding this recall call 407-475-4717.
Quantity in Commerce 231 (38 US; 193 OUS)
Distribution Worldwide Distribution - USA including CA, CO, CT, FL, GA, IL, NY, NY NC OH, TX, VA, WV, WI. Internationally to: AUSTRALIA, AUSTRIA, BAHARIN, CANADA, CHILE, CHINE, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GEORGIA, GERMANY, HONG KONG, INDIA, INDONESIA, ITALY, JAPAN, KOREA, MEXICO, MOROCCO, NIGERIA, POLAND, ROMANIA, RUSSIA,SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED KINGDOM.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = GE HEALTHCARE
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