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Terminated

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.

FDA Recall Z-1551-2013 · Posted 2013-06-18

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeJAK
Date Initiated2013-05-09
Date Terminated2014-01-21
Product Quantity231 (38 US; 193 OUS)

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K063324PET VCARGE Healthcare · 2007-03-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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