Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.
This recall has been terminated (originally issued July 11, 2016).
- Company
- Merge Healthcare, Inc.
- Recall Initiated
- January 31, 2016
- Posted
- July 11, 2016
- Terminated
- January 26, 2017
- Recall Number
- Z-2159-2016
- Quantity
- 49 sites have the affected software
- Firm Location
- Hartland, WI
- Official Source
- View on FDA website ↗
Reason for Recall
Potential data loss occurs as a result of product archiving not working properly.
Distribution
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.
Lot / Code Info
Version 3.4
Root Cause
Software design
Action Taken
The recalling firm issued a letter dated 1/27/2016 via e-mail on 1/31/2016 explaining the reason for recall and instructing the customer to provide a copy of the notification to all users.
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