Merge RadSuite software. Radiological image processing system.
Reported: September 14, 2016 Initiated: April 9, 2015 #Z-2715-2016
Product Description
Merge RadSuite software. Radiological image processing system.
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.
Details
- Recalling Firm
- Merge Healthcare, Inc.
- Units Affected
- 10 sites have the affected software that is configured with the specific conditions listed in Code Information
- Distribution
- Distribution was made to medical facilities in AL, MI, MO, PA, TN, and TX.
- Location
- Hartland, WI
Frequently Asked Questions
What product was recalled? ▼
Merge RadSuite software. Radiological image processing system.. Recalled by Merge Healthcare, Inc.. Units affected: 10 sites have the affected software that is configured with the specific conditions listed in Code Information.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 14, 2016. Severity: Moderate. Recall number: Z-2715-2016.
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