Z-1109-2014Class II

Philips HeartStart XL, Defibrillator/Monitor Model number M4735A

Name: Z-1109-2014 Philips HeartStart XL, Defibrillator/Monitor Model number M4735A
Creator: Philips Medical Systems, Inc.
Published: 2014-02-14
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-02-14 / Terminated / root cause: design

FDA source

Philips Medical Systems, Inc. began a recall of Philips HeartStart XL, Defibrillator/Monitor Model number M4735A Product Usage: The M4735A HeartStart XL Defibrillator/Monitor is for use in the hospital by... on 2014-02-14. FDA classified it as Class II and gives the reason as "Philips HeartStart XL may experience a power board failure causing failure to defibrillate". 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-1109-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-14
Posted: 2014-02-26
Terminated: 2016-06-16
Recalling firm: Philips North America LLC
Product: Philips HeartStart XL, Defibrillator/Monitor Model number M4735A Product Usage: The M4735A HeartStart XL Defibrillator/Monitor is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation. It must be used by or on the order of a physician. When operating as a semi-automatic external defibrillator in AED Mode, the M4735A HeartStart XL Defibrillator/Monitor is suitable for use by medical personnel trained in basic life support that includes the use of an AED
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Philips HeartStart XL may experience a power board failure causing failure to defibrillate
Root cause tag: design
FDA root cause: Component design/selection
Action: Philips Healthcare issued an Urgent Medical Device Correction notification/Field Safety Notice dated February 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were informed Philips Healthcare Representative will perform a hardware upgrade free of charge. Customers were instructed while awaiting the replacement power board for your device, you may continue to use the HeartStart XL. Identify a readily available backup defibrillator to use in the event the affected HeartStart XL fails to deliver therapy. If you need any further information or support concerning this issue, please contact your local Philips representative at 1-800-722-9377
Quantity in commerce: 5234 units
Distribution: Worldwide Distribution and USA Nationwide and the countries of AUSTRALIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, ETHIOPIA, FINLAND, FRANCE, GEORGIA, GERMANY, HUNGARY, INDIA, INDONESIA, IRELAND, ITALY, JAPAN, KAZAKHSTAN, KOREA, REPUBLIC OF, MALAYSIA, MEXICO, MONACO, NEPAL, NETHERLANDS, PORTUGAL, SINGAPORE, SOUTH AFRICA, SPAIN, SRI LANKA, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, and VIET NAM,
Product codes and lots: Serial numbers within the range: US00101665 through US00608704 Units manufactured by Philips between May, 2013 and November, 2013.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1109-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1109-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-26

Product code MKJ

K051134Class IIIHeartstart Mrx with Q-CPR Option, Models M3535a or M3536aPhilips Medical Systems / cleared 2005-09-08

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)