Philips Ambulance Parameter Extension Kit Recalled for ECG Signal Loss
Philips is recalling 43 Ambulance Parameter Extension kits because they may cause ECG 'Leads Off' errors in hot, humid environments.
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 medical device where a functional failure (ECG 'Leads Off') poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Philips North America, LLC is recalling 43 units of the Ambulance Parameter Extension (APE) kit M4758A. This accessory is intended for use with the Philips HeartStart MRx Monitor/Defibrillator in EMS environments.
The recall was issued because the kit may cause an ECG 'Leads Off' condition when used in hot, humid environments. This issue could affect the reliability of the monitor/defibrillator system.
The affected units were distributed internationally in Austria, Germany, the Netherlands, Norway, Poland, and Switzerland. Users should contact Philips for further instructions regarding the recall.
The recalled product
- Product
- Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx Monitor/Defibrillator - Product Usage: is intended to be used with the M3536A MRx in EMS environments.
- Manufacturer
- Philips North America, LLC
- Hazard
- Affected units
- 43
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
Distribution
Distribution scope not specified by the agency.
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