Reported Apr 14, 2021 · Ongoing
Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on…
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. · 81 Hartwell Ave Ste 300 · Lexington, MA · 02421-3160
Is this the product you have?
- Synapse PACS - Radiological
- Image Processing System - Product Usageintended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with FUJIFILM Synapse PACS Software (Server)
- Lot codes and dates
- Software version5.1 to 5.7.200
- Amount recalled
- 839 systems
Where it was sold
Why it was recalled
The wrong patient information may be displayed in the viewer or PowerJacket.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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