Recall record at a glance
| Official record | Z-2440-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | LivaNova Deutschland GmbH |
| Report date | Jul 8, 2020 |
| Recall initiation date | Aug 26, 2019 |
| Quantity | 24 |
| Location | Munich, N/A, Germany |
Official product description
Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly, UDI: 04033817900986
Why the product 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.
Distribution information
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
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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