Reported Sep 14, 2016 · Terminated
Merge RadSuite software. Radiological image processing system.
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 RadSuite software. Radiological image processing system.
- Lot codes and dates
- RadSuite Versions
5.30.85.35.35.35.45.35.58.30.7.38.30.7.48.30.7.58.30.7.7 are affectedBUT ONLY if they are configured
- with all of the following conditions(1) Must have IPID enabled; (2) Must use IPID morphers (3) Must Define a Defaultvalue in the IPID Morpher; (4) Must use the Aggregating Morpher; (5) Must not set OverwritelfPresent=false; and (6) Must be on an internal store (this is data that is already present on EA being stored to Radsuite, this excludes direct DICOM stores to the EA)
- RadSuite Versions
- Amount recalled
- 10 sites have the affected software that is configured with the specific conditions listed in Code Information
Where it was sold
Why it was recalled
When RadSuite is used with IPID (Issuer of Patient ID) as a part of the "Patient Identifier," it is possible in some circumstances that the demographics of one patient will be applied to a study or studies for another patient.
This product could cause temporary or reversible health problems — stop using it.
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