Reported Jul 8, 2020 · Terminated
Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI: 04033817900993
LivaNova Deutschland GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LivaNova Deutschland GmbH · Lindberghstr. 25 · Munich, N/A · N/A
Is this the product you have?
- Control Panel REF - 60-02-50LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly
- UDI04033817900993
- Lot codes and dates
- Serial Number
60S1473560S1487760S1471560S1471660S1473660S1475560S1470760S14708
- Serial Number
- Amount recalled
- 8
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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