Z-2440-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 8, 2020
- Initiation Date
- August 26, 2019
- Termination Date
- April 22, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24
Product Description
Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly, UDI: 04033817900986
Reason for Recall
The SCP control Panel rotary knob used to control rotary speed of the pump in the SCP system used as a centrifugal pump during cardiopulmonary bypass may be difficult or impossible to rotate as a result of premature wear of the angle encoder. The loss of function of the angle encoder during bypass may lead to ischemia, stroke, organ damage, arterial tissue injury or reperfusion syndrome.
Distribution Pattern
US: FL, GA, IN, KY, MI, MO, NY, OH, PA, SC, TN, TX, VA OUS: Canada - Uzbekistan - Turkey - Tunisia - Taiwan - South Africa - Serbia - Saudi Arabia - Russia - Poland - Mexico - Korea(Rep. of) - India - Hong Kong - Colombia - China - Brazil - Bahrain - Argentina - Algeria - Italy - Germany
Code Information
Serial Number: 60S14838 60S14839 60S14829 60S14724 60S14850 60S14858 60S14732 60S14737 60S14844 60S14846 60S14854 60S14855 60S14777 60S14778 60S14725 60S14727 60S14784 60S14785 60S14845 60S14774 60S14775 60S14786 60S14830 60S14776 60S14882