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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 Initiated by Firm May 09, 2013
Date Posting Updated June 18, 2013
Recall Status1 Terminated 3 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = GE HEALTHCARE
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