Z-0273-2016Class II

ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside monitor for Synchronized...

Name: Z-0273-2016 ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside monitor for Synchronized...
Creator: Philips Electronics North America Corporation
Published: 2014-11-19
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-11-19 / Terminated / root cause: design

FDA source

Philips Electronics North America Corporation began a recall of ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside monitor for Synchronized cardioversion and Transcutaneous pacing. M1783A/M5526A... on 2014-11-19. FDA classified it as Class II and gives the reason as "When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor via a sync cable, the following can occur if the monitor/defibrillator experiences interference from electrical fast...". 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-0273-2016
Classification: Class II
Status: Terminated
Initiated: 2014-11-19
Posted: 2015-11-13
Terminated: 2017-09-12
Recalling firm: Philips North America LLC
Product: ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside monitor for Synchronized cardioversion and Transcutaneous pacing. M1783A/M5526A 12-pin Sync cables, used with HeartStart MRx and HeartStart XL and HeartStart XL+
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor via a sync cable, the following can occur if the monitor/defibrillator experiences interference from electrical fast transients (EFTs) while connected to AC power: On the HeartStart MRx and HeartStart XL, EFT noise can be misinterpreted as an R-wave. On the HeartStart XL+, EFT noise can disable ECG monitoring, and potentially interrupt demand mode pacing.
Root cause tag: design
FDA root cause: Device Design
Action: Philips sent an Urgent - Field Safety Notice dated November, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Philips plans to take to remedy the issue. A replacement cable will be provided free of charge for all units affected by this issue. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the upgrade. 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: Prior to receiving a replacement sync cable, you can continue to use affected sync cables, provided that they are only used to connect the ECG Out jack on the monitor/defibrillator to the ECG (input) port on a bedside monitor. The issues described in this letter do not impact this application of the sync cable. Affected sync cables should not be used to connect the ECG Out jack of a bedside monitor to the ECG (input) port on the monitor/defibrillator. For further questions please call (800) 722-9377.
Quantity in commerce: 18,604
Distribution: Worldwide Distribution - US (nationwide) and to the countries of : Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Ethiopia, Finland, France, Gabon, Germany, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kenya, Republic of Korea, Latvia, Lebanon, Macau, Malaysia, Mexico, Netherlands, New Zealand, Nigeria, Norway, Oman, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela and Yemen.
Product codes and lots: All Philips M1783A and M5526A sync cables are affected by this issue. The model number is printed on the outside of the cable, near the end with the ¿ inch phone plug.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0273-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0273-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-13

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)