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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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…
- Manufacturer
- Philips Healthcare Inc.
- Category
- Medical Device — Defibrillators
- Affected units
- 2,500
Distribution
Distributed nationwide across the United States.
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