Recall Z-2235-2023— Virtual Radiologic Corp.

Name: FDA recall Z-2235-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-09

Class II · Ongoing

Class II FDA medical device recall by Virtual Radiologic Corp., initiated 2023-05-09. It names one FDA 510(k) clearance: K162145. Product: vRad PACS with Mammography. Reason: The error resulted in intermittent failure of current (primary) radiology study images not displaying to the interpreting teleradiologist..

Recalling firm: Virtual Radiologic Corp.
Classification: Class II
Status: Ongoing
Initiated: 2023-05-09
Firm location: Eden Prairie, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K162145 — vRad PACS with MammographyVirtual Radiologic Corporation·cleared 2016-10-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.