Agency classClass IIOur severity:Severe FDA (Devices)·Z-2347-2012·Announced 2012-09-19

Philips HeartStart MRx Monitor Defibrillators Recalled for Cable Wear

Philips is recalling HeartStart MRx monitor/defibrillators because wear on the therapy cable connection may cause the device to fail to detect defibrillation pads or paddles.

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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects in critical medical devices, are classified as Severe (4).

Plain-English summary

Philips Healthcare Inc. is recalling approximately 58,701 units of HeartStart MRx monitor/defibrillators. The affected models include M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M1, M3536M2, M3536M3, M3536M4, M3536M5, and M3536M6. These devices are intended for use by qualified medical personnel to terminate ventricular tachycardia and ventricular fibrillation.

The recall is due to wear on the therapy cable connection, which may lead to a malfunction in the detection of defibrillation pads or paddles. This issue specifically affects units manufactured prior to June 2012 that are used in external transport and Emergency Medical Service (EMS) environments.

The affected devices were distributed worldwide, including nationwide in the United States and in numerous other countries. Healthcare facilities and EMS providers should check their inventory for these specific models and contact Philips for instructions on how to address the defect.

The recalled product

Product: Philips HeartStart MRx monitor/defibrillators Models: M3535A and M3536A, M3536J, M3536M, M3536MC, M3536M1, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6 The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for…
Manufacturer: Philips Healthcare Inc.
Category: Medical Device — Cardiac Monitoring and Defibrillation
Hazard: malfunction
failure-to-detect
Affected units: 58,701

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)

distributed worldwide

Distribution

Distributed nationwide across the United States.

Same manufacturer · Philips Healthcare Inc.

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Same hazard · malfunction