Recall Z-2715-2016 ยท LLZ System, Image Processing, Radiological
Merge Healthcare, Inc.
Merge RadSuite software. Radiological image processing system.
| Date | Sep 2, 2016 (initiated Apr 9, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | The recalling firm issued letters dated 4/3/2015 via email on 4/9/2015 notifying the customer of the issues. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053281 | EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE) Emageon, Inc., Dec 7, 2005 |