FDA recall Z-2235-2023

Virtual Radiologic Corp. · Class II · device

Product

vRad PACS with Mammography

Reason for recall

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

Distribution

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

Key facts

Status
Ongoing
Initiation date
2023-05-09
Report date
2023-08-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Eden Prairie, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2235-2023