Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables Recalled by Philips Electronics North America Corporation Due to Issue with ECG out cables. When a Philips...

Date: July 17, 2017
Company: Philips Electronics North America Corporation
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Philips Electronics North America Corporation directly.

Affected Products

ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units of Philips sync cables model M1783A and M5526A as well as Philips ECG out cables model 989803195641. Manufactured - September 4, 2002 October 8, 2014

Quantity: 15811

Why Was This Recalled?

Issue with ECG out cables. When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor via a sync cable or ECG out cable, the following can occur if the monitor/defibrillator experiences interference from electrical fast transients (EFTs): " On the HeartStart MRx and HeartStart XL, EFT noise may be misinterpreted as an R-wave. " On the HeartStart XL+, EFT noise can disable ECG monitoring and potentially interrupt demand mode pacing*. *Note: It is contrary to the XL+ Instructions for Use to perform demand mode pacing while using the ECG out cable or obtaining the ECG signal from a bedside monitor. The XL+ Instructions for Use includes the following warning: When pacing in Demand Mode, the ECG cable from the patient must be directly connected to the HeartStart XL+. If the user follows this warning, this problem cannot occur on the XL+.

Where Was This Sold?

1067 US customers 163 Canada, 917 International

About Philips Electronics North America Corporation

Philips Electronics North America Corporation has 160 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report