Merge HEMO software.
This recall has been terminated (originally issued August 4, 2016).
- Company
- Merge Healthcare, Inc.
- Recall Initiated
- July 2, 2012
- Posted
- August 4, 2016
- Terminated
- June 26, 2017
- Recall Number
- Z-2341-2016
- Quantity
- 37
- Firm Location
- Hartland, WI
- Official Source
- View on FDA website ↗
Reason for Recall
The International Normalized Ratio (INR) value displayed in the study report does not match the value that is imported on the pre-procedure labs screen from HL7
Distribution
The medical facilities who currently have the affected versions are located nationwide. There was government distribution but no military or foreign distribution.
Lot / Code Info
Software versions 8.10, 9.10, 9.20.
Root Cause
Software design
Action Taken
The firm issued an "Important Product Information" bulletin to customers dated 7/2/2012 via e-mail letting them know there was an upgrade available. On 1/30/2016, the recalling firm initiated phone calls to their customers letting them know there was an upgrade available and if they declined it, they would like a written response.