vRad PACS medical imaging system recalled for intermittent image display failures
Virtual Radiologic's vRad PACS with Mammography system may intermittently fail to display radiology images, preventing radiologists from viewing diagnostic studies. Eight units across seven U.S. states are affected by this Class II recall.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a software-based medical device where functionality failure could impair clinical diagnosis. The source reports no illnesses, injuries, or deaths, which per the rubric limits severity to 3 for risk-of-harm products without reported injury.
Plain-English summary
Virtual Radiologic Corp. is recalling the vRad PACS with Mammography system, a software system used in healthcare facilities to archive and display radiology images for interpretation by radiologists. Eight units with software versions 23.2 Build 23.2.0.117 through 23.4 Build 23.4.25.1 are included in the recall.
The system experiences an intermittent software error that causes primary radiology study images to fail to display to the interpreting teleradiologist. This prevents radiologists from accessing images needed for patient diagnosis.
The affected systems have been distributed across seven U.S. states: Maryland, Minnesota, Tennessee, Florida, Georgia, Texas, and Oklahoma.
The FDA classified this recall as Class II. Affected healthcare facilities should contact Virtual Radiologic Corp. regarding this recall.
The recalled product
- Product
- vRad PACS with Mammography
- Manufacturer
- Virtual Radiologic Corp.
- Hazard
- Affected units
- 8
Distribution
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