Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Merge Hemo Recalled by Merge Healthcare, Inc. Due to A system freeze-up of the Merge Hemo system,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Merge Healthcare, Inc. directly.
Affected Products
Merge Hemo, 9.10, 9.20.0, 9.20.1,9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 with Massimo PHASEIN End Tidal CO2 (EtCO2) module. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.
Quantity: 451
Why Was This Recalled?
A system freeze-up of the Merge Hemo system, that included the PHASEIN End Tidal CO2 unit, resulted in the user needing to move the patient to another cath lab.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Merge Healthcare, Inc.
Merge Healthcare, Inc. has 93 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report