Philips HeartStart XL Defibrillator Recalled for Rotary Switch Failure
Philips is recalling HeartStart XL Defibrillators because a faulty switch may prevent the device from turning on or delivering the correct 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 agency classification is Class II, and the defect involves a critical life-support device where failure to deliver appropriate therapy could result in significant injury or death.
Plain-English summary
Philips North America, LLC is recalling the Philips HeartStart XL Defibrillator/Monitor (Model number M4735A). The recall involves 94,034 units that were distributed worldwide and nationwide in the United States. The product has been discontinued.
The recall is due to a potential failure of the rotary therapy selector switch. This failure may result in unexpected device behavior, including the device not turning on, failing to perform the selected function, or delivering a shock with an energy level different from the user's selection. In these scenarios, appropriate therapy delivery may be delayed.
This device is intended for use in hospitals by qualified medical personnel trained in basic life support, advanced cardiac life support, or defibrillation. It must be used by or on the order of a physician. Users should contact Philips for further instructions regarding the recall.
The recalled product
- Product
- Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation.…
- Manufacturer
- Philips North America, LLC
- Category
- Medical Device — Defibrillator
- Affected units
- 94,034
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. Product has been discontinued.
Distribution
Distributed nationwide across the United States.
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