Merge RadSuite software. Radiological image processing system.
This recall has been terminated (originally issued September 2, 2016).
- Company
- Merge Healthcare, Inc.
- Recall Initiated
- April 9, 2015
- Posted
- September 2, 2016
- Terminated
- August 24, 2017
- Recall Number
- Z-2715-2016
- Quantity
- 10 sites have the affected software that is configured with the specific conditions listed in Code Information
- Firm Location
- Hartland, WI
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Distribution was made to medical facilities in AL, MI, MO, PA, TN, and TX.
Lot / Code Info
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).
Root Cause
Software design
Action Taken
The recalling firm issued letters dated 4/3/2015 via email on 4/9/2015 notifying the customer of the issues.