Reported Nov 27, 2019 · Terminated
HeartStart XL+ Defibrillator/Monitor, Model 861290
Philips North America, LLC
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: Philips North America, LLC · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- HeartStart XL+ Defibrillator/Monitor, Model 861290
- Lot codes and dates
- All units manufactured prior to 1 May 2017.
- Amount recalled
- 23,749 Units
Where it was sold
- Nationwide
Why it was recalled
The rotary therapy selector switch may fail, resulting in unexpected device behavior. These behaviors include: The device may not turn on; The device may not perform the selected function; The device may deliver a shock with an energy level different from the setting selected by the user.
This product could cause temporary or reversible health problems — stop using it.
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