Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system.
FDA Recall Z-2865-2016 · Posted None
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Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2016-01-30
Date Terminated2017-12-15
Product Quantity42 sites potentially have the affected version
Reason for Recall
Patient information in the header is only found on the first page of the report and not on the subsequent pages.
Firm Action
Merge sent an Urgent Medical Device Recall letter dated January 28, 2016 to affected customers via e-mail or via certified mail if they did not have an e-mail address. The letter identified the affected product, problem and actions to be taken. For questions call Merge Customer Service at (877)741-5369 or [email protected].
Root Cause
Software design
Distribution Pattern
US Nationwide Distribution
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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