FDA Device recall Z-1107-2014
Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified medica…
- FDA Device
- Class II
- terminated
- Published 2014-03-05
On 2014-03-05 the FDA classified a Class II recall of Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified medica… by Philips Medical Systems, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1107-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-01-24 |
| Published | 2014-03-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems |
| Distribution | US |
Product
Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 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.
Reason
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
Identifiers
| code_info | Serial Numbers: Serial Number Range USO1100106-USO1100372 USN1100376-USN1100960 USD1100961-USD1101095 US11201095-U…Serial Numbers: Serial Number Range USO1100106-USO1100372 USN1100376-USN1100960 USD1100961-USD1101095 US11201095-US11201186 US21201187-US21201239 US31201240-US31201537 US41201538-US41201585 US51201586-US51201721 US61201722-US61201924 US71201925-US71202048 US81202049-US81202168 US91202169-US91202514 US01202515-US01202990 USN1202991-USN1203537 USD1203538-USD1203968 US11303969-US11303972 US21303980-US21304488 US31304489-US31305042 US41305043-US41305295 US51305296-US51305450 US61305451-US61306138 US71306139-US71306542 US81306543-US81306998 US91306999-US91307261 US01307306-US01307458 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1107-2014%22
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