GE Healthcare, PET VCAR. PET VCAR application software is affected if installed on any of the following versions of the
FDA device recall Z-1551-2013 · posted 2013-06-18 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 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, FR
- Date initiated
- 2013-05-09
- Date posted
- 2013-06-18
- Date terminated
- 2014-01-21
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PET VCAR (K063324) | GE Healthcare | 2007-03-23 |