| Date Initiated by Firm | May 09, 2023 |
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| Date Posted | July 21, 2023 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2235-2023 |
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| 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 |
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Manufacturer Reason
for Recall | The error resulted in intermittent failure of current (primary) radiology study images not displaying to the interpreting teleradiologist. |
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FDA Determined
Cause 2 | Software Manufacturing/Software Deployment |
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| 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. |
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| Quantity in Commerce | 8 units |
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| Distribution | US Nationwide distribution in the states of MD, MN, TN, FL, GA, TX, OK. |
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| 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.
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| 510(K) Database | 510(K)s with Product Code = LLZ
|
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