Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring system that records and displays physiological data.
This recall has been terminated (originally issued April 4, 2016).
- Company
- Merge Healthcare, Inc.
- Recall Initiated
- April 4, 2016
- Terminated
- August 5, 2019
- Recall Number
- Z-1457-2017
- Quantity
- 361 sites potentially have the affected versions
- Firm Location
- Hartland, WI
- Official Source
- View on FDA website ↗
Reason for Recall
In some instances, the system will lock tabs within a study, even when a second user does not have the study open on a different workstation.
Distribution
US Nationwide Distribution.
Lot / Code Info
Versions 6.10, 6.10.1, 6.10.2, 6.10.3, 7.10, 7.20, 7.20.1, 8.10.0, 8.20, 9.10.0, 9.20, 9.20.2, 9.20.3, 9.30, 9.40, 9.40.1, 9.40.2, and 9.40.3
Root Cause
Software design
Action Taken
The recalling firm issued a letter dated March 28, 2016 via e-mail. If no email address was available, the letters were issued via certified mail. Non-responders were issued letters on July 11, 2016. The letter identified the affected product, problem and actions to be taken. For question send an email to recall@merge.com.
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