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
FDA Recall Z-1778-2017 · Posted 2017-04-11
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Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeDQK
Date Initiated2016-04-04
Date Terminated2019-02-21
Product Quantity24 sites potentially have the affected versions
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.
Firm Action
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 [email protected].
For questions regarding this recall call 877-741-5369.
Root Cause
Software design
Distribution Pattern
Nationwide Distribution including AZ, CA, CO, FL, GA, KS, LA, MI, MO, OH, OK, TN, TX, VA, WA, WI, and WV.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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