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Terminated

Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI.

FDA Recall Z-1403-2017 · Posted 2017-03-03

Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2016-04-04
Date Terminated2019-07-26
Product Quantity110 sites potentially have the affected versions

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.

Firm Action

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.

Root Cause

Software design

Distribution Pattern

Distribution was made to medical facilities nationwide. There was no foreign/military/government distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051649VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0Camtronics Medical Systems · 2005-08-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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