Reported Dec 28, 2016 · Terminated
Merge OrthoCase 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?
- Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Lot codes and dates
- Versions
2.02.12.1.13.13.23.2.43.33.3.13.43.5.13.5.1.13.5.23.5.33.5.43.5.53.63.6.13.6.23.73.7.13.7.23.7.2 Vetand 3.7.3
- Versions
- Amount recalled
- 30 sites potentially have the effected versions
Where it was sold
Why it was recalled
Measurements in the software are changing after saving a plan with a measurement result, which may result in potential patient injury or delay in diagnosis or treatment.
This product could cause temporary or reversible health problems — stop using it.
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