Recall Z-2439-2020 ยท DWA Control, Pump Speed, Cardiopulmonary Bypass
LivaNova Deutschland GmbH
Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI: 04033817900993
| Date | Aug 26, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | The firm issued an Urgent Field Safety Notice, SCP Control panel (Subset) dated August 29, 2019 via USPS on August 29, 2019 to inform consignees that LivaNova is executing a voluntary medical device correction a limited subset of SCP control panels (references 60-02-15 & 60-02-50) due to an observed trend in reported complaints. The letter describes immediate action to be taken by customers. It states: LivaNova is initiating the proactive replacement of potentially affected angle encoder lots in the field in order to reduce the likelihood of the occurrence of the above described issue. Actio |
| Quantity | 8 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011838 | CENTRIFUGAL PUMP Stockert Instrumente GmbH, Feb 5, 2002 |