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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Merge Hemo with software versions 9.10, 9.20.0, 9.20.1, 9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 are affected only if used with any Masimo PHASEIN EtCO2 module
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Merge Healthcare, Inc.
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
Merge Hemo with software versions 9.10, 9.20.0, 9.20.1, 9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 are affected only if used with any Masimo PHASEIN EtCO2 module
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2347-2015
Related Recalls
Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schiller ARGUS PB-3000 Patient Data Module (PDM) where certain units trigger an error message on the Merge Hemo Client ( Pressure Sensor Defective ) during non-invasive blood pressure (NIBP) measurements, specifically when the initial inflation pressure is set in the high-pressure range (>240 mmHg). The ARGUS PB-3000 is a vital signs monitoring instrument intended to be integrated into the Merge Hemo System. No other components of the Merge Hemo System are affected.
When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.
When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.