Reported Oct 19, 2016 · Terminated
Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and…
Fujifilm Medical Systems U.S.A., Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fujifilm Medical Systems U.S.A., Inc. · 419 West Ave · Stamford, CT · 06902-6343
Is this the product you have?
- Fujifilm Synapse PACS
- Software versions4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all modalities
- Lot codes and dates
- Software versions
4.0.xxx4.1.xxxversion 4.2.xxxversion 4.3.xxx
- Software versions
- Amount recalled
- 251 units
Where it was sold
- Nationwide
Why it was recalled
Image data for a patients image may not be correct
This product could cause temporary or reversible health problems — stop using it.
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