Device product

vRad PACS with Mammography

Z-2235-2023

May 09, 2023

Class II

Product summary

Firm: Virtual Radiologic Corp.
Event: Event 92516
Status: Ongoing
Classification: Class II
Quantity: 8 units
Official record key: device-enforcement:Z-2235-2023

Official wording

Reason: The error resulted in intermittent failure of current (primary) radiology study images not displaying to the interpreting teleradiologist.

Code information: (01)00862234000313(10)23.2 Build 23.2.0.117 through (01)00862234000313(10) 23.4 Build 23.4.25.1

Distribution pattern: US Nationwide distribution in the states of MD, MN, TN, FL, GA, TX, OK.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

The error resulted in intermittent failure of current (primary) radiology study images not displaying to the interpreting teleradiologist.