Device product
Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.
Z-2159-2016
Product summary
- Event
- Event 74510
- Status
- Terminated
- Classification
- Class II
- Quantity
- 49 sites have the affected software
- Official record key
device-enforcement:Z-2159-2016
Official wording
Reason: Potential data loss occurs as a result of product archiving not working properly.
Code information: Version 3.4
Distribution pattern: Distribution was made to medical facilities located in AL, AZ, CA, CO, CT, FL GA, ID, IL, KY, MA, MO, NE, NH, NJ, NY, NC, OK, PA, SC, TN, VA, and WA. There was no government/military/foreign distribution.
Derived failure modes
-
Unknown
Potential data loss occurs as a result of product archiving not working properly.