Fujifilm Synapse PACS recall
Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system…
Why was Fujifilm Synapse PACS recalled?
Image data for a patients image may not be correct
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?
Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx
- Product
- Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system…
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- Quantity
- 251 units
- Distribution
- US Nationwide Distribution.
- Recall date
- October 19, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)