CLASS II Device recall · Reported 24 Jan 2018 · FDA Enforcement Report

ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync recalled

Philips Electronics North America is recalling ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units of Philips sync, distributed nationwide in the US. The recall was initiated on 17 Jul 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesM1783A/M5526A 12-pin Sync cables All units of Philips sync cables model M1783A and M5526A as well as Philips ECG out cables model 989803195641

Quantity recalled15811

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0348-2018
FDA event ID: 78702
Recalling firm: Philips Electronics North America, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 17 Jul 2017
FDA classified: 14 Jan 2018
Reported: 24 Jan 2018
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Patient Monitors

Timeline

17 Jul 2017	Recall initiated by company
14 Jan 2018	Classified by FDA	+181 days
24 Jan 2018	Published in enforcement report	+10 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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+.

Product as listed by the FDA

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

Where it was distributed

1067 US customers 163 Canada, 917 International

Nationwide

Questions about this recall

Is ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units of Philips sync recalled?

Yes. Philips Electronics North America recalled ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units of Philips sync on 17 Jul 2017. The recall is Class II and its status is Terminated. Recall number Z-0348-2018.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

1067 US customers 163 Canada, 917 International

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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