Merge Unity Z3D software. Merge Unity PACS recall: Software Issue
Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a medical image and information management system that allows viewing…
Why was Merge Unity Z3D software. Merge Unity PACS recalled?
The software is unable to accurately determine the calcium score of scans with a slice thickness not equal to 3 mm.
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
- Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a medical image and information management system that allows viewing…
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 9 sites potentially have the affected version
- Distribution
- US Distribution to states of: CA, PA, TX, and MT.
- Recall date
- August 24, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)