Z-2235-2023 Class II Ongoing
FDA device recall Z-2235-2023 was initiated by Virtual Radiologic Corp. on May 9, 2023 and is designated Class II. Reason for recall: The error resulted in intermittent failure of current (primary) radiology study images not displaying to the interpreting teleradiologist. The recall status is ongoing. Affected quantity: 8 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 2, 2023
- Initiation Date
- May 9, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 units
Product Description
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 Pattern
US Nationwide distribution in the states of MD, MN, TN, FL, GA, TX, OK.
Code Information
(01)00862234000313(10)23.2 Build 23.2.0.117 through (01)00862234000313(10) 23.4 Build 23.4.25.1