Synapse PACS Software Versions 5.1 and higher recall
Synapse PACS Software Versions 5.1 and higher
Why was Synapse PACS Software Versions 5.1 and higher recalled?
There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT studies may be returned for Siemens Modality.
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?
Software Versions 5.1, 5.2, 5.3, 5.4, 5.5, and 5.7.
- Product
- Synapse PACS Software Versions 5.1 and higher
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- Quantity
- 235
- Distribution
- Software was distributed to medical facilities nationwide throughout the U.S.
- Recall date
- January 27, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)