Z-0571-2025 Class II Ongoing
FDA device recall Z-0571-2025 was initiated by LivaNova Deutschland GmbH on October 18, 2024 and is designated Class II. Reason for recall: 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 oc… The recall status is ongoing. Affected quantity: 38.
Recall Details
- Product Type
- Devices
- Report Date
- December 4, 2024
- Initiation Date
- October 18, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 38
Product Description
Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of CA, VA, GA, IN, NJ, FL, CO, MS, NV.
Code Information
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