DR Systems Unity PACS software recall: Software Issue
DR Systems Unity PACS software, now known as Merge Unity PACS software.
Why was DR Systems Unity PACS software recalled?
The software fails to associate to the correct MG image if there are two images for the same view.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Version 11.0
- Product
- DR Systems Unity PACS software, now known as Merge Unity PACS software.
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 9 sites potentially have the effected software
- Distribution
- Distribution was made to medical facilities located in MT, CA, PA, and TX.
- Recall date
- January 11, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)