Reported Aug 12, 2015 · Terminated
Philips HeartStart XL+ Defibrillator/Monitor Product Usage: The HeartStart XL+ is intended for use in a hospital…
Philips Electronics North America Corporation
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 Electronics North America Corporation · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- Philips HeartStart XL+
- Defibrillator/Monitor Product UsageThe HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defibrillation. When operating as a semi-automatic external defibrillator in AED Mode, the HeartStart XL+ is suitable for use by medical personnel trained in basic life support that includes the use of an AED. When operating in Monitor, Manual Defibrillation or Pacing modes, the HeartStart XL+ is suitable for use by healthcare professionals trained in advance life support
- Lot codes and dates
- Serial Numbers in the following ranges
USO1100100 to USD1101095US11201096 to USD1203968US11303969 to USD1309471US11409472 to US61414022
- Serial Numbers in the following ranges
- Amount recalled
- 13,168 devices
Where it was sold
- Nationwide
- PR
Why it was recalled
Multiple software and hardware issues with device that can affect its function.
This product could cause temporary or reversible health problems — stop using it.
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