FDA Device recall Z-2439-2020
Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI: 04033817900993
- FDA Device
- Class II
- terminated
- Published 2020-07-08
On 2020-07-08 the FDA classified a Class II recall of Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI: 04033817900993 by Livanova Deutschland, citing 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 impossibl….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2439-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-26 |
| Published | 2020-07-08 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Livanova Deutschland |
| Distribution | FL, GA, IN, KY, MI, MO, NY, OH, PA, SC, TN, TX, VA |
Product
Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI: 04033817900993
Reason
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.
Identifiers
| code_info | Serial Number: 60S14735 60S14877 60S14715 60S14716 60S14736 60S14755 60S14707 60S14708 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2439-2020%22
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