Philips HeartStart XL Monitor/Defibrillators Recalled for Missing Field Action Corrections
Philips is recalling 130 HeartStart XL Monitor/Defibrillators because they may not have received required corrections from prior field actions.
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 is classified as FDA Class II, which indicates a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences. The hazard involves a critical life-support device potentially lacking required safety corrections.
Plain-English summary
Philips North America, LLC is recalling 130 units of the HeartStart XL Monitor/Defibrillators (Model M4735A). The recall was initiated because these specific units may not have been included in prior field actions and therefore may not have received the required corrections.
The affected devices are intended for use in hospitals by qualified medical personnel trained in basic life support, advanced cardiac life support, or defibrillation. The recall covers 126 units in the United States and 4 units outside the US. Distribution included the US states of Kentucky, Massachusetts, North Dakota, and New York, as well as the United Kingdom and Bahrain.
Hospitals and medical facilities should check their inventory against the provided serial numbers to determine if they possess affected units. If a unit is found, it should be removed from service and the manufacturer contacted for further instructions.
The recalled product
- Product
- Philips HeartStart XL Monitor/Defibrillators 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
Distribution
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