Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI.
This recall has been terminated (originally issued March 3, 2017).
- Company
- Merge Healthcare, Inc.
- Recall Initiated
- April 4, 2016
- Posted
- March 3, 2017
- Terminated
- July 26, 2019
- Recall Number
- Z-1403-2017
- Quantity
- 110 sites potentially have the affected versions
- Firm Location
- Hartland, WI
- Official Source
- View on FDA website ↗
Reason for Recall
When taking measurements from images on the Cardio workstation or from the US cart, numbers are not crossing to the report in the correct unit of measure.
Distribution
Distribution was made to medical facilities nationwide. There was no foreign/military/government distribution.
Lot / Code Info
Versions 9.0, 9.0.1, 9.0.2, 9.0.3, 9.0.4, 9.0.5, 9.0.6, 9.0.7, 9.0.8, 9.0.9, and 10.0.
Root Cause
Software design
Action Taken
Merge sent an Urgent : Medical Device Recall letter dated March 28, 2016. If no email address was available, the letters were issued via certified mail. Nonresponders were issued a second letter dated July 11, 2016. For further questions, please call (877) 741-5369.
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