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U.S. Department of Health and Human Services

Class 2 Device Recall vRad

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  Class 2 Device Recall vRad see related information
Date Initiated by Firm May 09, 2023
Date Posted July 21, 2023
Recall Status1 Open3, Classified
Recall Number Z-2235-2023
Recall Event ID 92516
510(K)Number K162145  
Product Classification System, image processing, radiological - Product Code LLZ
Product vRad PACS with Mammography
Code Information (01)00862234000313(10)23.2 Build 23.2.0.117 through (01)00862234000313(10) 23.4 Build 23.4.25.1
Recalling Firm/
Manufacturer		 Virtual Radiologic Corp.
11995 Singletree Ln Ste 500
Eden Prairie MN 55344-5349
For Additional Information Contact
952-595-1100
Manufacturer Reason
for Recall		 The error resulted in intermittent failure of current (primary) radiology study images not displaying to the interpreting teleradiologist.
FDA Determined
Cause 2		 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 in Commerce 8 units
Distribution US Nationwide distribution in the states of MD, MN, TN, FL, GA, TX, OK.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = Virtual Radiologic Corporation
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