FUJIFILM Synapse PACS Software: versions 7.0.0 and recall: Software Issue
FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which…
Why was FUJIFILM Synapse PACS Software: versions 7.0.0 and recalled?
The software does not update measurements and calculations in the Clinical Reporting Application (CRA) when the ventricular trace is changed in the study by a different user.
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?
Versions 7.0.0 and 7.0.1
- Product
- FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which…
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- Quantity
- 1 unit
- Distribution
- US Nationwide distribution in the state of MD.
- Recall date
- February 3, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)