Philips Recalls Two HeartStart MRx Monitor/Defibrillators for Missing Corrections
Philips North America, LLC is recalling two HeartStart MRx Monitor/Defibrillators because they may not have received applicable 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Philips North America, LLC is recalling two units of the HeartStart MRx Monitor/Defibrillator, Model # M3535A. The recall involves specific units identified by serial numbers US00539461 and US00539462. These devices were distributed in the state of Massachusetts.
The recall is being conducted because the non-conforming devices may not have been included in prior field actions and may not have had a number of corrections applicable to these devices. The HeartStart MRx is a lightweight, portable external defibrillator designed for use by clinicians trained in Advanced Cardiac Life Support (ACLS) or Basic Life Support (BLS). It offers manual and semi-automatic modes of operation for defibrillation and ECG monitoring.
Users of the affected devices should contact Philips North America, LLC for further instructions regarding the necessary corrections. The recall is classified as Class II by the U.S. Food and Drug Administration.
The recalled product
- Product
- HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The HeartStart MRx is a lightweight, portable external defibrillator, offering two modes of operation for defibrillation: manual mode and semi-automatic mode (AED). In manual mode, the HeartStart MRx is a full…
- Manufacturer
- Philips North America, LLC
- Category
- Medical Device — Defibrillator
- Hazard
- Affected units
- 2
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)
- Lot/ Serial # US00539461
- US00539462
Distribution
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