Philips HeartStart XL Defibrillators Recalled for Battery Failure Risk
Philips is recalling HeartStart XL Defibrillators used with specific M3516A batteries that may fail without warning, potentially causing the device to shut down unexpectedly during use.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a medical device shutting down unexpectedly without warning during use, which poses a significant risk of injury or death to patients, fitting the criteria for a Severe rating.
Plain-English summary
Philips Healthcare Inc. is recalling approximately 2,500 units of the HeartStart XL M4735A Defibrillator/Monitor. The recall involves devices used with M3516A batteries labeled "Made in Taiwan" with a Date of Manufacture of R-2011-12. These devices are intended for use by qualified medical personnel in hospital environments.
The recall is due to a risk that the battery may fail while the device is operating on AC power is not in use. If this occurs, the device may shut down unexpectedly without providing the user with a low battery warning message or audible tone. This could interrupt critical medical treatment.
The affected products were distributed worldwide, including in the United States and numerous other countries. Users should stop using the affected devices and contact Philips Healthcare for instructions on repair or replacement.
The recalled product
- Product
- Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL Defibrillator/Monitor is a fully featured, defibrillator intended for use by qualified medical personnel, trained in either Advanced Cardiac Life Support or in the operation
- Manufacturer
- Philips Healthcare Inc.
- Category
- Medical Device — Defibrillators
- Affected units
- 2,500
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Philips Healthcare Inc.
See all →- ModeratePhilips Recalls Mobile Diagnostic X-Ray Systems Due to Marker Placement Error
FDA (Devices) · 2017-04-12
- HighPhilips IntellVue Info Center Patient Monitor Recall for Reboot Loop
FDA (Devices) · 2014-06-18
- ModeratePhilips Easy Upgrade DR Recalled for Potential Image Marker Misinterpretation
FDA (Devices) · 2013-09-04
- LowPhilips MobileDiagnost wDR Recalled for Non-Compliant Instructions for Use
FDA (Devices) · 2013-08-28
- ModeratePhilips IntelliVue Smart-hopping 1.4 GHz Access Point Recalled for Signal Loss
FDA (Devices) · 2013-07-31
Same hazard · battery failure
See all →- HighOdyne Recalls Hybrid Systems Due to Traction Battery Fire Risk
NHTSA · 2026-08-12
- HighHeartMate 3 assist system kits recalled over backup battery failures
FDA (Devices) · 2026-06-24
- HighHeartMate 11 volt lithium ion backup batteries may fail
FDA (Devices) · 2026-06-24
- HighHeartMate 3 system controllers recalled over backup battery failures
FDA (Devices) · 2026-06-24
- SevereElgin Pelican Recall: High Voltage Battery Fire Risk
NHTSA · 2026-06-24