Z-1155-2014Class II

Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A...

Name: Z-1155-2014 Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A...
Creator: Philips Medical Systems, Inc.
Published: 2014-02-18
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-02-18 / Terminated / root cause: design

FDA source

Philips Medical Systems, Inc. began a recall of Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A, M3536M,M3536M4,M3536M6,861288,861289,861464,861483,and 861491 on 2014-02-18. FDA classified it as Class II and gives the reason as "MRx may display a Red X in the Ready For Use (RFU) indicator during automated tests informing the user that a failure has been detected that may prevent the delivery of a shock and pacing". 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-1155-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-18
Posted: 2014-03-07
Terminated: 2020-09-11
Recalling firm: Philips North America LLC
Product: Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A, M3536M,M3536M4,M3536M6,861288,861289,861464,861483,and 861491
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: MRx may display a Red X in the Ready For Use (RFU) indicator during automated tests informing the user that a failure has been detected that may prevent the delivery of a shock and pacing
Root cause tag: design
FDA root cause: Component design/selection
Action: Philips Healthcare issued and Urgent Medical Device Correction notification/Field Safety Notice on 02/18/14 to inform customers of the issue, 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: You can continue to use your MRx prior to receiving the hardware upgrade, provided that if you observe that the MRx is displaying a Red X in the Ready For Use (RFU) indicator\during automated tests, a failure has been detected that may prevent the delivery of a shock or pacing due to this issue. If this is observed you should turn the Therapy Knob to Monitor. An INOP message describing the failure is displayed. If needed, run an Operational Check for further information. If the condition persists, take the device out of use and call for service. Identify a readily available backup defibrillator to use in the event the affected HeartStart MRx fails to deliver therapy. Philips will perform a hardware upgrade (replace therapy boards) free of charge to be installed by a Philips Field Service Engineer. Contact your local Philips representative or call us at 1-800-722-9377.
Quantity in commerce: 3541 units
Distribution: Nationwide Foreign: AUSTRIA BAHRAIN BELGIUM BRAZIL CANADA CHINA EGYPT ESTONIA FINLAND FRANCE GERMANY GHANA ICELAND INDIA INDONESIA IRELAND ISRAEL ITALY JAPAN JORDAN KENYA KOREA, REPUBLIC OF LATVIA LEBANON LIBYAN ARAB JAMAHIRIYA LITHUANIA MALAYSIA MEXICO MOZAMBIQUE MYANMAR (Burma) NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NORWAY PAKISTAN PERU POLAND PORTUGAL QATAR RUSSIAN FEDERATION SAUDI ARABIA SINGAPORE SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TAIWAN, PROVINCE OF CHINA THAILAND TURKMENISTAN UNITED ARAB EMIRATES UNITED KINGDOM VIET NAM
Product codes and lots: Serial numbers within the range: US00100204 to US00570921

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1155-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1155-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-07

Product code MKJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)