Philips HeartStart XL+ Defibrillator Recall Due to Switch Failure
Philips is recalling HeartStart XL+ Defibrillators because a faulty switch may cause the device to fail or deliver incorrect shock energy.
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 and involves a medical device that may deliver incorrect shock energy, posing a significant risk of injury.
Plain-English summary
Philips North America, LLC is recalling 23,749 units of the HeartStart XL+ Defibrillator/Monitor, Model 861290. The recall covers all units manufactured prior to May 1, 2017, which were distributed nationwide in the United States.
The recall is due to a potential failure of the rotary therapy selector switch. This defect may result in unexpected device behavior, including the device failing to turn on, failing to perform the selected function, or delivering a shock with an energy level different from the user's selection.
Consumers should contact Philips for further instructions regarding the recall and replacement or repair of the affected devices.
The recalled product
- Product
- HeartStart XL+ Defibrillator/Monitor, Model 861290
- Manufacturer
- Philips North America, LLC
- Category
- Medical Device — Defibrillator
- Affected units
- 23,749
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 (1)
- All units manufactured prior to 1 May 2017.
Distribution
Distributed nationwide across the United States.
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