Philips HeartStart XL+ Defibrillator Recalled for Battery Charge Time Labeling Error
Philips is recalling 7,157 HeartStart XL+ Defibrillators because the battery charge time at high temperatures is slightly longer than the 3 hours stated in the labeling.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a minor labeling error regarding battery charge time without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Philips Medical Systems, Inc. is recalling 7,157 units of the HeartStart XL+ Defibrillator/Monitor (Model 861290). The recall is due to a labeling inaccuracy regarding the device's battery performance. Specifically, the time required to charge the battery to 100% capacity at 35°C (95°F) is slightly longer than the 3-hour duration specified in the product labeling.
The affected devices were distributed worldwide, including the United States (nationwide) and Puerto Rico, as well as numerous countries across Africa, Asia, Europe, and the Americas. The HeartStart XL+ is intended for use in hospital settings by qualified medical personnel trained in basic life support, advanced life support, or defibrillation.
No specific corrective actions or consumer instructions are provided in the source text beyond the identification of the labeling discrepancy. Users should verify their device serial numbers against the provided ranges to determine if their unit is affected.
The recalled product
- 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…
- Manufacturer
- Philips Medical Systems, Inc.
- Category
- Medical Device — Defibrillator
- Hazard
- Affected units
- 7,157
Distribution
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