vRad PACS with Mammography — Class II medical device recall Z-2235-2023
Ongoing recall by Virtual Radiologic Corp., reported 2023-08-02, distributed nationwide. The error resulted in intermittent failure of current (primary) radiology study images not displaying to the i
| Recall number | Z-2235-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Virtual Radiologic Corp., Eden Prairie, MN, United States |
| Recall initiated | 2023-05-09 |
| Classified | 2023-07-21 |
| Reported by FDA | 2023-08-02 |
| Distributed | Nationwide (US) |
| Quantity | 8 units |
| UPC / GTIN / UDI-DI | 00862234000313 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2235-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.