Reported Aug 31, 2016 · Terminated
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Merge Healthcare, 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: Merge Healthcare, Inc. · 900 Walnut Ridge Dr · Hartland, WI · 53029-8347
Is this the product you have?
- RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Lot codes and dates
- Versions
5.30.75.30.7 HF0429E5.30.7 HF0441E5.30.7 HF0446E5.30.7 HF0470E5.30.7 HF0473E5.30.85.30.8 HF0477E5.30.8 HF0490E5.30.8 HF0495 SB0508E5.30.8 HF0495E5.30.8 HF0495ESB504E5.30.8 HF05505.30.8 SB0485E5.30.8 SB0486E5.30.X SB0381E5.35.15.35.1 HF0487E5.35.1 HF0489E5.35.25.35.35.35.4and 5.35.4 HF0513
- Versions
- Amount recalled
- 25 sites potentially have the affected versions
Where it was sold
Why it was recalled
Potential for RadSuite AV viewer to skip image slices when the user presses page up or page down when the viewer displays multiple viewports and the user has mouse focused on any viewport other than the first viewport.
This product could cause temporary or reversible health problems — stop using it.
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