Control Panel REF — Class II medical device recall Z-2439-2020

Terminated recall by LivaNova Deutschland GmbH, reported 2020-07-08, distributed in FL, GA, IN, KY, MI, MO, NY, OH…. The SCP control Panel rotary knob used to control rotary speed of the pump in the SCP system used as a centrif

Recall number	`Z-2439-2020`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	LivaNova Deutschland GmbH, Munich, N/A, Germany
Recall initiated	2019-08-26
Classified	2020-06-26
Reported by FDA	2020-07-08
Terminated	2021-04-22
Distributed	FL, GA, IN, KY, MI, MO, NY, OH, PA, SC, TN, TX, VA
Countries outside the US	AR, BH, BR, CA, CN, CO, DE, DZ, HK, IN, IT, KR, MX, PL, RS, RU, SA, TN, TR, TW, ZA
Quantity	8
UPC / GTIN / UDI-DI	`04033817900993`
Serial numbers	`60S14707`, `60S14708`, `60S14715`, `60S14716`, `60S14735`, `60S14736`, `60S14755`, `60S14877`
Model numbers	`60-02-50`, `IPX2`

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2439-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.