Agency classClass IIOur severity:Severe FDA (Devices)·Z-2794-2020·Announced 2020-08-19

Philips HeartStart MRx Monitor/Defibrillators Recalled for Therapy Switch Failure

Philips is recalling HeartStart MRx monitor/defibrillators because a therapy switch failure may prevent the device from delivering the intended shock energy or function.

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 medical device failure that could result in a failure to deliver intended therapy, which aligns with the rubric criteria for Severe severity (FDA Class II with potential for significant injury or adverse health consequences).

Plain-English summary

Philips North America, LLC is recalling approximately 95,212 units of the HeartStart MRx Monitor/Defibrillators. The affected model numbers include M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, and M3536M9. These devices were distributed worldwide and are intended for use in hospital and pre-hospital settings by qualified medical personnel.

The recall is due to a potential failure of the therapy switch. If this component fails, the device may not perform the selected function, the therapy knob may not change to the selected energy setting, or the device may deliver a shock with an energy level different from the user's selection. These behaviors could result in a delay in therapy or a failure to deliver the intended therapy.

Healthcare facilities and users should contact Philips for further instructions on how to address this issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9 - Product Usage: is intended for use in hospital and pre-hospital settings by qualified medical personnel…
Manufacturer: Philips North America, LLC
Category: Medical Device — Cardiac Monitoring / Defibrillation
Hazard: device-malfunction
therapy-delay
incorrect-energy-delivery
Affected units: 95,212

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 devices are affected

Distribution

Distribution scope not specified by the agency.

Same manufacturer · Philips North America, LLC

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