CLASS II Device recall · Reported 8 Jul 2020 · FDA Enforcement Report
Control Panel recalled by LivaNova Deutschland
LivaNova Deutschl is recalling Control Panel, distributed in 13 states. The recall was initiated on 26 Aug 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2440-2020
- FDA event ID
- 85505
- Recalling firm
- LivaNova Deutschl, Munich, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Aug 2019
- FDA classified
- 26 Jun 2020
- Reported
- 8 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 26 Aug 2019 | Recall initiated by company | |
| 26 Jun 2020 | Classified by FDA | +305 days |
| 8 Jul 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly, UDI: 04033817900986
Where it was distributed
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
FloridaGeorgiaIndianaKentuckyMichiganMissouriNew YorkOhioPennsylvaniaSouth CarolinaTennesseeTexasVirginia
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 85505| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Control Panel recalled by LivaNova Deutschland | LivaNova Deutschl | Other | 13 states |
More recalls from LivaNova Deutschl
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Essenz HLM (Heart-Lung Machine) recalled by LivaNova Deutschland | LivaNova Deutschl | Device Malfunction | Nationwide |
| Device | CLASS II | 3T Heater Cooler System recalled by LivaNova Deutschland | LivaNova Deutschl | Other | Nationwide |
| Device | CLASS III | Sorin Centrifugal Pump System, CP5, Drive Unit recalled | LivaNova Deutschl | Device Malfunction | FL, NE, TX |
| Device | CLASS II | Control Panel recalled by LivaNova Deutschland | LivaNova Deutschl | Other | 13 states |
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