Device product
Merge RadSuite software. Radiological image processing system.
Z-2715-2016
Product summary
- Event
- Event 74853
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10 sites have the affected software that is configured with the specific conditions listed in Code Information
- Official record key
device-enforcement:Z-2715-2016
Official wording
Reason: 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.
Code information: RadSuite Versions: 5.30.8, 5.35.3, 5.35.4, 5.35.5, 8.30.7.3, 8.30.7.4, 8.30.7.5, 8.30.7.7 are affected, BUT 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).
Distribution pattern: Distribution was made to medical facilities in AL, MI, MO, PA, TN, and TX.
Derived failure modes
-
Unknown
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.