Z-0348-2018Class II

ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units of Philips sync cables model M1783A...

Name: Z-0348-2018 ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units of Philips sync cables model M1783A...
Creator: Philips Electronics North America Corporation
Published: 2017-07-17
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2017-07-17 / Terminated / root cause: design

FDA source

Philips Electronics North America Corporation began a recall of 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... on 2017-07-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0348-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-17
Posted: 2018-01-14
Terminated: 2018-07-12
Recalling firm: Philips North America LLC
Product: 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
Product code: MKJ Automated External Defibrillators (Non-Wearable)
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+.
Root cause tag: design
FDA root cause: Device Design
Action: Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice: Customers should remove affected sync cables and ECG out cables from service and destroy them, documenting such action on the attached reply form, which should be returned to Philips. Customers should retain a copy of the reply form. The customer should follow the Instructions for Use that describe the recommended approach for performing cardioversion with the XL+ and MRx monitor/defibrillators. The ECG trunk cable can be disconnected from the Philips bedside monitor and connected to the monitor/defibrillator before delivering therapy; this is the preferred source of an ECG waveform for synchronization.
Quantity in commerce: 15811
Distribution: 1067 US customers 163 Canada, 917 International
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0348-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0348-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-24	2018-01-14

Product code MKJ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)