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Open, Classified

vRad PACS with Mammography

FDA Recall Z-2235-2023 · Posted 2023-07-21

Recalling FirmVirtual Radiologic Corp.
Recall StatusOpen, Classified
Product CodeLLZ
Date Initiated2023-05-09
Product Quantity8 units

Reason for Recall

The error resulted in intermittent failure of current (primary) radiology study images not displaying to the interpreting teleradiologist.

Firm 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.

Root Cause

Software Manufacturing/Software Deployment

Distribution Pattern

US Nationwide distribution in the states of MD, MN, TN, FL, GA, TX, OK.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K162145vRad PACS with MammographyVirtual Radiologic Corporation · 2016-10-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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