Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure

FDA Recall Z-1091-2017 · Posted None

Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeDQK
Date Initiated2016-03-28
Date Terminated2019-06-28
Product Quantity242 sites potentially have the affected versions

Reason for Recall

There is a potential connection issue when powering up the Merge Hemo Record Station and the Hemo Monitor does not communicate with the Client PC.

Firm Action

MERGE sent an Urgent Medical Device Recall letter dated July 11, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to reply using the enclosed form and ensure all users of the product are provided with the notification. Customers with questions were instructed to send an email to [email protected]..

Root Cause

Software design

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082421HEARTSUITE HEMODYNAMICS 7.10Emageon, Inc. · 2008-12-17

Official Source

View FDA Recall →

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

↑