Reported Mar 5, 2014 · Terminated
Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 The HeartStart XL+ is intended for use in a hospital setting…
Philips Medical Systems, Inc.
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 Medical Systems, Inc. · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- Philips HeartStart XL+
- Defibrillator/Monitor Model861290 The 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 NumbersSerial Number Range
USO1100106-USO1100372USN1100376-USN1100960USD1100961-USD1101095US11201095-US11201186US21201187-US21201239US31201240-US31201537US41201538-US41201585US51201586-US51201721US61201722-US61201924US71201925-US71202048US81202049-US81202168US91202169-US91202514US01202515-US01202990USN1202991-USN1203537USD1203538-USD1203968US11303969-US11303972US21303980-US21304488US31304489-US31305042US41305043-US41305295US51305296-US51305450US61305451-US61306138US71306139-US71306542US81306543-US81306998US91306999-US91307261US01307306-US01307458
- Serial NumbersSerial Number Range
- Amount recalled
- 7157 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
HeartStart XL+ battery charge time to 100% capacity at 35¿C (95¿F) is slightly longer than the specified 3 hour duration as stated in the labeling
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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