CLASS II Device recall · Reported 16 Apr 2014 · FDA Enforcement Report

Philips HeartStart XL+ Defibrillator/Monitor with system recalled

Philips Medical Systems is recalling Philips HeartStart XL+ Defibrillator/Monitor with system, distributed nationwide in the US. The recall was initiated on 2 Apr 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUSO1100106 to USO1100372 USN1100376 to USN1100960 USD1100961 to USD1101095 US11201096 to US11201186 US21201187 to US21201239 US31201240 to US31201537 US41201538 to US41201585 US51201586 to US51201721 US61201722 to US61201924 US71201925 to US71202048 US81202049 to US81202168 US91202169 to US91202514 USO1202515 to USO1202990 USN1202991 to USN1203537 USD1203538 to USD1203968 US11303969 to US11303972 US21303980 to US21304488 US31304489 to US31305042 US41305043 to US41305295 US51305296 to US51305450 US61305451 to US61306138 US71306139 to US71306542 US81306543 to US81306998 US91306999 to US91307261 USO1307306 to USO1307458 USN1307616 to USN1308423 USD1308424 to USD1309471 US11409472 to US11410212 US21410213 to US21410563

Quantity recalled9872 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1438-2014
FDA event ID: 67862
Recalling firm: Philips Medical Systems, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 2 Apr 2014
FDA classified: 9 Apr 2014
Reported: 16 Apr 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Pacemakers & Defibrillators

Timeline

2 Apr 2014	Recall initiated by company
9 Apr 2014	Classified by FDA	+7 days
16 Apr 2014	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Software communication failure may occur on the HeartStart XL+ locking the user out of clinical mode and possibly causing a delay in therapy.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or B.00.01 installed Model: 861290, automatic external defibrillator.

Where it was distributed

Worldwide Distribution - USA (nationwide) including the countries of: ARGENTINA AUSTRALIA AUSTRIA BELGIUM CANADA CHINA CZECH REPUBLIC DENMARK FRANCE GERMANY ITALY LATVIA NETHERLANDS NEW ZEALAND NORWAY PHILIPPINES PORTUGAL SOUTH KOREA SPAIN SWITZERLAND THAILAND TURKEY and UNITED KINGDOM.

Nationwide

Questions about this recall

Why was it recalled?

Software communication failure may occur on the HeartStart XL+ locking the user out of clinical mode and possibly causing a delay in therapy.

Which lots are affected?

USO1100106 to USO1100372 USN1100376 to USN1100960 USD1100961 to USD1101095 US11201096 to US11201186 US21201187 to US21201239 US31201240 to US31201537 US41201538 to US41201585 US51201586 to US51201721 US61201722 to US61201924 US71201925 to US71202048 US81202049 to US81202168 US91202169 to US91202514 USO1202515 to USO1202990 USN1202991 to USN1203537 USD1203538 to USD1203968 US11303969 to US11303972 US21303980 to US21304488 US31304489 to US31305042 US41305043 to US41305295 US51305296 to US51305450 US61305451 to US61306138 US71306139 to US71306542 US81306543 to US81306998 US91306999 to US91307261 USO1307306 to USO1307458 USN1307616 to USN1308423 USD1308424 to USD1309471 US11409472 to US11410212 US21410213 to US21410563

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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