Philips Recalls HeartStart MRx Lithium-Ion Batteries Due to Defective Component
Philips is recalling 1,880 HeartStart MRx lithium-ion batteries because a defective component may prevent the battery from charging or delivering power to the monitor/defibrillator.
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 (monitor/defibrillator) where a component failure could prevent operation, posing a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Philips North America LLC is recalling 1,880 HeartStart MRx rechargeable lithium-ion batteries (REF: M3538A). These batteries are components used in HeartStart MRx Monitor/Defibrillators. The recall is due to a potential defect in the Thermal Cut-off (TCO) component.
If the TCO component fails, the battery will no longer charge or deliver power to the monitor/defibrillator. This failure may prevent the device from operating if it is not connected to AC or DC power. If a second, unaffected battery is present in the device, the failure of the defective battery may go unnoticed.
The affected batteries were distributed in 32 U.S. states and numerous foreign countries. The specific serial numbers for the affected units range from 17362-0001-P through 18057-0266-P. Users should check their battery serial numbers against this range and contact Philips for further instructions.
The recalled product
- Product
- HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx Monitor/Defibrillators.
- Manufacturer
- Philips North America LLC
- Affected units
- 1,880
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)
- UDI: (01)00884838002791
- Serial Numbers: 17362-0001-P through 18057-0266-P
Distribution
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