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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 Device 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
510(K)Number K063324 
Product Classification System, tomography, computed, emission - 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 WI 53188-1615
For Additional Information Contact
262-513-4122
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
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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