vRad PACS with Mammography
This recall is currently active, issued July 21, 2023. It was issued by Virtual Radiologic Corp..
- Company
- Virtual Radiologic Corp.
- Recall Initiated
- May 9, 2023
- Posted
- July 21, 2023
- Recall Number
- Z-2235-2023
- Quantity
- 8 units
- Firm Location
- Eden Prairie, MN
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
(01)00862234000313(10)23.2 Build 23.2.0.117 through (01)00862234000313(10) 23.4 Build 23.4.25.1
Root Cause
Software Manufacturing/Software Deployment
Action Taken
The firm issued an URGENT FIELD CORRECION notice to its consignees beginning on 06/28/2023 via email. The notice explained the issue, root cause, and repair of the software. It was recommended that those consignees who experienced the malfunction review the affected cases.