Reported Jul 8, 2020 · Terminated
Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly, UDI: 04033817900986
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 - 60-02-15LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly
- UDI04033817900986
- Lot codes and dates
- Serial Number
60S1483860S1483960S1482960S1472460S1485060S1485860S1473260S1473760S1484460S1484660S1485460S1485560S1477760S1477860S1472560S1472760S1478460S1478560S1484560S1477460S1477560S1478660S1483060S1477660S14882
- Serial Number
- Amount recalled
- 24
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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new LivaNova Deutschland GmbH recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.