Device product

Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automated chemistry analyzer intended for clinical use

Z-0154-2020

January 10, 2012

Class II

Product summary

Firm: Vital Scientific N.V.
Event: Event 83582
Status: Terminated
Classification: Class II
Quantity: 4 units
Official record key: device-enforcement:Z-0154-2020

Official wording

Reason: The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.

Code information: serial numbers: 11-1302, 11-303, 11-304 , 11-1305

Distribution pattern: US Nationwide in the states of NY, and UT

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.