Recall Z-2235-2023 ยท LLZ System, Image Processing, Radiological
Virtual Radiologic Corp.
vRad PACS with Mammography
| Date | Jul 21, 2023 (initiated May 9, 2023) |
| Status | Open, Classified |
| Reason | The error resulted in intermittent failure of current (primary) radiology study images not displaying to the interpreting teleradiologist. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | 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. |
| Quantity | 8 units |
| Distribution | US Nationwide distribution in the states of MD, MN, TN, FL, GA, TX, OK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162145 | vRad PACS with Mammography Virtual Radiologic Corporation, Oct 25, 2016 |