Device product
enGen Track System with TCAutomation Software Version 4.2
Z-0254-2018
Product summary
- Event
- Event 77172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16
- Official record key
device-enforcement:Z-0254-2018
Official wording
Reason: A software anomaly with TCA Software V4.2 may potentially cause a delay in reporting of results due to patient samples being routed to an unintended location when samples are reintroduced back onto the enGEN track
Code information: Serial numbers: 5GV6W2J, 3RHC23J, 7KSC15J, 953252, CXL941J & JG7BFB5J Product Code 952019-EG, 952020-EG, 952055
Distribution pattern: Domestically - GA, IL, MO, NC & NY; Internationally - Canada, England, France, Italy & Spain
Derived failure modes
-
Device software or design
software anomaly