vRad PACS with Mammography
FDA device recall Z-2235-2023 · posted 2023-07-21 · Open, Classified
Recall details
- Recalling firm
- Virtual Radiologic Corp.
- Reason for recall
- The error resulted in intermittent failure of current (primary) radiology study images not displaying to the interpreting teleradiologist.
- 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.
- Root cause
- Software Manufacturing/Software Deployment
- Status
- Open, Classified
- Product code
- LLZ
- Quantity affected
- 8 units
- Distribution
- US Nationwide distribution in the states of MD, MN, TN, FL, GA, TX, OK.
- Date initiated
- 2023-05-09
- Date posted
- 2023-07-21
- Location
- Eden Prairie, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| vRad PACS with Mammography (K162145) | Virtual Radiologic Corporation | 2016-10-25 |