Reported Sep 21, 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
- This potential patient safety issue is only present in the following versions
- when a reverse workflow is used
2004-R6.x5.10.x5.205.255.30.15.30.25.30.2 SB03445.30.35.30.45.30.4 HF0418E5.30.55.30.5 HF0404E5.30.5 HF0413E5.30.5 HF390E5.30.5 SB03685.30.65.30.6 HF0405E5.30.6 HF0406E5.30.75.30.7 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 HF0495E SB504E5.30.8 HF05505.30.8 SB0485E5.30.8 SB0486E5.30.X SB0381E5.35.15.35.1 HF0487E5.35.1 HF0489E5.35.25.35.35.35.45.35.4 HF05135.35.4 HF05185.35.4 HF05285.35.4 HF05315.35.4 HF05355.35.4 HF05468.30.0
- NOTEThe standard workflow is not impacted
- Amount recalled
- 45 sites potentially have the affected versions
Where it was sold
Why it was recalled
Multiple studies were missing at a customer location that never made it to the archive before watermarking
This product could cause temporary or reversible health problems — stop using it.
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