# FDA recall Z-2439-2020

> **LivaNova Deutschland GmbH** · Class II · device recall initiated 2019-08-26.

## Product

Control Panel REF - 60-02-50:  LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI:   04033817900993

## 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

- **Recall number:** Z-2439-2020
- **Recalling firm:** LivaNova Deutschland GmbH
- **Classification:** Class II
- **Product type:** device
- **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

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2439-2020

## Citation

> AI Analytics. FDA recall Z-2439-2020. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-2439-2020. Source: US FDA. Licensed CC0.

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