vRad PACS with Mammography recallZ-2235-2023 · Virtual Radiologic Corp. · initiated May 9, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Virtual Radiologic Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The error resulted in intermittent failure of current (primary) radiology study images not displaying to the interpreting teleradiologist.
FDA root cause category: Software Manufacturing/Software Deployment
What the company is doing
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.
Recall details
- Recall number
- Z-2235-2023
- Status
- Open, Classified
- Initiated by the company
- May 9, 2023
- Posted by the FDA
- Jul 21, 2023
- Recalling firm
- Virtual Radiologic Corp.
- Quantity
- 8 units
- Product code
- LLZ
- FDA submissions
- K162145
- Distribution
- US Nationwide distribution in the states of MD, MN, TN, FL, GA, TX, OK.
Product description
vRad PACS with Mammography
Code information (models, lots, serial numbers)
(01)00862234000313(10)23.2 Build 23.2.0.117 through (01)00862234000313(10) 23.4 Build 23.4.25.1
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- vRad PACS 2Virtual Radiologic Corporation · System, Image Processing, Radiological1 recall1 death1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page