Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0554-2016 — 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.

U.S. FDA — Device Enforcement · United States · 2015-10-26 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0554-2016
Date of alert: 2015-10-26
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Merge Healthcare, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-0554-2016 — 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.

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