Device product
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
Z-1176-2017
Product summary
- Event
- Event 76260
- Status
- Terminated
- Classification
- Class II
- Quantity
- 29 sites have the potentially affected software
- Official record key
device-enforcement:Z-1176-2017
Official wording
Reason: Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment.
Code information: Version 7.0.1
Distribution pattern: Distribution was made to medical facilities in AZ, CA, CO, FL, HI, IL, MA, MD, MI, MO, NY, OH, PA, SC, TN, UT, and WI. There was no foreign/government/military distribution.
Derived failure modes
-
Unknown
Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment.