Philips HeartStart XL+ Defibrillator Recall for Power-On Failure
Philips is recalling 24,738 HeartStart XL+ Defibrillator/Monitor units because they may fail to turn on or restart, rendering them unable to return to a ready-for-use state.
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 could prevent emergency treatment, but the source text does not report any specific injuries, illnesses, or fatalities, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips North America, LLC is recalling 24,738 units of the HeartStart XL+ Defibrillator/Monitor, Model 861290. The recall covers all units of this model distributed nationwide in the United States.
The device is being recalled because it may fail to turn on or unexpectedly attempt to restart. This issue can occur when the device is in standby mode or when attempting to power on to run a self-test. If this failure occurs, the device will indicate that it is not ready for use.
Healthcare facilities and users should check their inventory for Model 861290 units. If a device is affected, it should be removed from service and returned to Philips for evaluation or replacement, as the device may be unable to return to a ready-for-use state.
The recalled product
- Product
- HeartStart XL+ Defibrillator/Monitor, Model 861290
- Manufacturer
- Philips North America, LLC
- Category
- Medical Device — Defibrillator
- Affected units
- 24,738
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 (2)
- All Units
- Model number 861290
Distribution
Distributed nationwide across the United States.
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