Merge PACS recall
Merge PACS, medical imaging diagnostic workstation
Why was Merge PACS recalled?
Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
UDI (01)00842000101215(10)9.4.0.P01(11)250916, (01)00842000101154(10)9.4.0.P02(11)260302 with Affected Versions: 9.4, 9.4 P01, and 9.4 P02.
- Product
- Merge PACS, medical imaging diagnostic workstation
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 53 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, and UK.
- Recall date
- August 12, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)