Agency classClass IIOur severity:High FDA (Devices)·Z-1194-2014·Announced 2014-03-19

Philips HeartStart MRx Monitor/Defibrillator Recalled for Q-CPR Meter Display Error

Philips is recalling HeartStart MRx Monitor/Defibrillators with the Q-CPR Meter option because the device may incorrectly display a 'Do Not Touch the Patient' icon during defibrillation mode.

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 (defibrillator) where a display error could impact the termination of life-threatening arrhythmias. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported, and it is not an FDA Class I recall.

Plain-English summary

Philips Medical Systems, Inc. is recalling 6,583 units of the HeartStart MRx Monitor/Defibrillator, specifically models M3535A and M3536A equipped with the Q-CPR Meter Option B08. The affected units have serial numbers ranging from US00100253 to US00571587. These devices are intended for use by qualified medical personnel to terminate ventricular tachycardia and ventricular fibrillation.

The recall was initiated because the Q-CPR Meter may incorrectly display the 'Do Not Touch the Patient' icon when the HeartStart MRx is used in defibrillation mode. This display error could potentially interfere with the proper operation of the device during critical medical procedures.

The affected devices were distributed worldwide, including nationwide in the United States and in numerous other countries such as Australia, Canada, Germany, and the United Kingdom. Medical facilities and users should check their device serial numbers against the specified range and contact Philips Medical Systems for further instructions on corrective actions.

The recalled product

Product: Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with Q-CPR Meter Option B08 The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the…
Manufacturer: Philips Medical Systems, Inc.
Category: Medical Device — Cardiac Monitoring / Defibrillation
Hazard: display-error
device-malfunction
Affected units: 6,583

Distribution

Distributed nationwide across the United States.

Same manufacturer · Philips Medical Systems, Inc.

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