Merge RadSuite software. Radiological image processing system.
FDA device recall Z-2715-2016 · posted 2016-09-02 · Terminated
Recall details
- Recalling firm
- Merge Healthcare, Inc.
- 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.
- Action taken
- The recalling firm issued letters dated 4/3/2015 via email on 4/9/2015 notifying the customer of the issues.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity 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.
- Date initiated
- 2015-04-09
- Date posted
- 2016-09-02
- Date terminated
- 2017-08-24
- Location
- Hartland, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE) (K053281) | Emageon, Inc. | 2005-12-07 |