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Terminated

Merge Cardio software.

FDA Recall Z-1486-2017 · Posted None

Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2016-04-04
Date Terminated2019-07-26
Product Quantity217 sites potentially have the affected versions

Reason for Recall

Cardio study list does not show STAT studies without refreshing.

Firm Action

The recalling firm issued a letter dated 3/28/2016 via e-mail the week of 4/4/2016. If no email address was available, the letters were issued via certified mail. Nonresponders were issued letters dated 7/11/2016.

Root Cause

Software design

Distribution Pattern

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