Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly Recalled by Merge Healthcare, Inc. Due to The firm, Merge Healthcare, sent out Merge HEMO...
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 with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.
Quantity: 2
Why Was This Recalled?
The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house.
Where Was This Sold?
This product was distributed to 3 states: IL, NC, VT
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