Philips HeartStart XL Defibrillators Recalled for Power Board Failure
Philips is recalling 5,234 HeartStart XL Defibrillators/Monitors because a power board failure may prevent the device from defibrillating.
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 critical medical device failure (failure to defibrillate) that poses a significant risk of serious injury or death to patients.
Plain-English summary
Philips Medical Systems, Inc. is recalling 5,234 units of the HeartStart XL Defibrillator/Monitor, model M4735A. The recall is due to a potential power board failure that could cause the device to fail to defibrillate. The affected units were manufactured between May 2013 and November 2013 and have serial numbers ranging from US00101665 through US00608704.
The affected devices were distributed worldwide, including in the United States and numerous other countries. The HeartStart XL 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.
Hospitals and medical facilities should identify affected units by checking the serial number and manufacturing date. Users should contact Philips Medical Systems for instructions on how to address the defect.
The recalled product
- Product
- Philips HeartStart XL, Defibrillator/Monitor Model number M4735A Product Usage: The M4735A HeartStart XL Defibrillator/Monitor 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…
- Manufacturer
- Philips Medical Systems, Inc.
- Category
- Medical Device — Defibrillator
- Affected units
- 5,234
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)
- 2013 and November
- 2013.
Distribution
Distributed nationwide across the United States.
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