Philips HeartStart XL+ Defibrillators Recalled for Potential Lockout
Philips is recalling 3,785 HeartStart XL+ defibrillators because they may become locked out of clinical use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device (defibrillator) where a functional failure (lockout) poses a risk of harm, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Philips Healthcare Inc. is recalling 3,785 units of the HeartStart XL+ Defibrillator/Monitor (Model 861290). The recall is due to a risk that the devices may become locked out of clinical use. The affected devices are intended for use in hospital settings by qualified medical personnel.
The recall covers units distributed worldwide, including the United States and numerous international locations. Specific serial number ranges are listed in the official recall notice. No specific dates of distribution or illness reports are provided in the source text.
Hospitals and medical facilities should contact Philips Healthcare Inc. for instructions on how to address the potential lockout issue. The source text does not specify a consumer action for general public, as the device is for professional medical use.
The recalled product
- Product
- Philips HeartStart XL+ Defibrillator/Monitor Model number: 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…
- Manufacturer
- Philips Healthcare Inc.
- Category
- Medical Device — Defibrillator
- Hazard
- Affected units
- 3,785
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- Serial number range: USO1100100 - USO1100372
- USN1100376 - USN1100960
- USD1100961 - USD1101095
- US11201096 - US11201186
- US21201187 - US21201239
- US31201240 - US31201537
- US41201538 - US41201585
- US51201586 - US51201721
- US61201722 -US61201924
- US71201925 - US71202048
- US81202049 - US81202168
- US91202169- US91202514
- USO1202515 - USO1202990
- USN1202991 - USN1203537
- USD1203538- USD1203968
- US11303969 - US11303972
Distribution
Distributed nationwide across the United States.
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