FDA Device recall Z-2440-2020
Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel
- FDA Device
- Class II
- terminated
- Published 2020-07-08
On 2020-07-08 the FDA classified a Class II recall of Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel 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-2440-2020 |
| 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 - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly, UDI: 04033817900986
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: 60S14838 60S14839 60S14829 60S14724 60S14850 60S14858 60S14732 60S14737 60S14844 60S14846 60S…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 |
|---|
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-2440-2020%22
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