FDAFDA · Food and drugs·Recall number Z-0571-2025
Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
Published December 4, 2024 · Recall initiated: October 18, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before reset, control maintained through backup control panel, but second reset may occur, may lead to gas blender standby, then gas blender must be reactivated using user interface on blender, sensors deactivated until new case started; GUI reset can lead to Hypoxia and Hypoperfusion.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- LivaNova Deutschland GmbH
- Distributor
- US Nationwide distribution in the states of CA, VA, GA, IN, NJ, FL, CO, MS, NV.
- Lot
- UDI-DI: 04033817903062. Software Version: 1.5. Serial Numbers: 49PK00436, 49PK00108, 49PK00374, 49PK00479, 49PK00480, 49PK00481, 49PK00093, 49PK00091, 49PK00092, 49PK00163, 49PK00497, 49PK00498, 49PK00219, 49PK00223, 49PK00224, 49PK00225, 49PK00226, 49PK00241, 49PK00255, 49PK00292, 49PK00291, 49PK00293, 49PK00490, 49PK00487, 49PK00488, 49PK00278, 49PK00274, 49PK00277, 49PK00275, 49PK00276, 49PK00273, 49PK00457, 49PK00458, 49PK00459, 49PK00455, 49PK00456, 49PK00290, 49PK00288
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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