FDA recall Z-2440-2020

Product

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

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

Key facts

Status

Terminated

Initiation date

2019-08-26

Report date

2020-07-08

Termination date

2021-04-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Munich, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2440-2020