Control Panel recall
Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly, UDI: 04033817900986
Why was Control Panel 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models 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
- Product
- Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly, UDI: 04033817900986
- Recalling firm
- LivaNova Deutschland GmbH
- Quantity
- 24
- Distribution
- 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
- Recall date
- July 8, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)