Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure
This recall has been terminated (originally issued April 11, 2017).
- Company
- Merge Healthcare, Inc.
- Recall Initiated
- April 4, 2016
- Posted
- April 11, 2017
- Terminated
- February 21, 2019
- Recall Number
- Z-1778-2017
- Quantity
- 24 sites potentially have the affected versions
- Firm Location
- Hartland, WI
- Official Source
- View on FDA website ↗
Reason for Recall
Use of the software may show an incorrect value to the user when viewing the Fractional Flow Reserve (FFR) results during recording.
Distribution
Nationwide Distribution including AZ, CA, CO, FL, GA, KS, LA, MI, MO, OH, OK, TN, TX, VA, WA, WI, and WV.
Lot / Code Info
Versions 9.10.0, 9.20.0, 9.20.1, 9.20.2, 9.30.3, and 9.40.0.
Root Cause
Software design
Action Taken
MERGE sent an Urgent Medical Device Recall letter dated April 4, 2016 to all affected customers via e-mail the week of April 4, 2016. If no email address was available, the letters were issued via certified mail. A second letter dated July 11, 2016 was issued to non-responders. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that all users of the affected product be provided with the notice. Customers were also asked to reply using the enclosed form and the return addressed envelope. Customers with questions were instructed to send an email to recall@merge.com. For questions regarding this recall call 877-741-5369.