Z-1417-2017Class I

HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC...

Name: Z-1417-2017 HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC...
Creator: Philips North America, LLC
Published: 2017-02-24
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2017-02-24 / Terminated / root cause: design

FDA source

Philips North America, LLC began a recall of HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7... on 2017-02-24. FDA classified it as Class I and gives the reason as "HeartStart MRx Monitor/Defibrillator may may exhibit abnormal behavior when operating using a single battery as the sole source of power may fail to deliver therapy or monitoring". 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-1417-2017
Classification: Class I
Status: Terminated
Initiated: 2017-02-24
Posted: 2017-03-24
Terminated: 2020-04-17
Recalling firm: Philips North America LLC
Product: HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: HeartStart MRx Monitor/Defibrillator may may exhibit abnormal behavior when operating using a single battery as the sole source of power may fail to deliver therapy or monitoring
Root cause tag: design
FDA root cause: Device Design
Action: Philips Healthcare issued an Urgent Medical Device Correction notification/Field Safety Notice. on 2/24/17. The Urgent Medical Device Correction notification/ Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. Action (1) Philips is voluntarily initiating this correction and is providing Instructions for Use (IFU) Addendum titled, HeartStart MRx Battery Connector Pins for all customers with affected units. 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: Philips is asking the customer when inspecting the device, to inspect the HeartStart MRx battery compartment connections. Include this step as part of a routine Operational Check to verify that the battery connector pins are clean, fully extended, not bent, and without residue. Action (2) Philips is voluntarily initiating this correction and is providing measures to prevent, or methods to allow the user to correct, the abnormal device behavior related to charging and pacing after disconnecting the device from AC mains.
Quantity in commerce: 97,794 total ( 47,362 US and 50,429 OUS)
Distribution: Worldwide Distribution-US (Nationwide) including PUERTO RICO and countries of: AFGHANISTAN, ALBANIA, ANGOLA, ARGENTINA, ARUBA, AUSTRALIA,AUSTRIA,AZERBAIJAN,BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA,BOSNIA AND HERZEGOWINA, BRAZIL,BRUNEI DARUSSALAM, BULGARIA,CAMBODIA,CANADA,CHILE,CHINA,COLOMBIA,COSTA RICA, CROATIA (local name: Hrvatska),CYPRUS,CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC,ECUADOR,EGYPT,EL SALVADOR, ESTONIA, ETHIOPIA,FINLAND,FRANCE,GABON,GERMANY,GHANA,GREECE, GUADELOUPE, HONG KONG,HUNGARY,ICELAND,INDIA, INDONESIA,IRAN (ISLAMIC REPUBLIC OF),IRAQ,IRELAND,ISRAEL,ITALY,JAPAN, JORDAN, KAZAKHSTAN, KENYA,KOREA, REPUBLIC OF,KUWAIT,LAOS,LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA,LITHUANIA,LUXEMBOURG, MACAU, MACEDONIA,MALAYSIA,MALTA,MAURITIUS,MEXICO,MONGOLIA, MOROCCO, MOZAMBIQUE,MYANMAR (Burma), NAMIBIA, NEPAL, NETHERLANDS, NETHERLANDS ANTILLES,NEW CALEDONIA,NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PALESTINE, PANAMA,PAPUA NEW GUINEA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL,QATAR,REUNION,ROMANIA,RUSSIAN FEDERATION,SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA,SOUTH AFRICA,SPAIN,SRI LANKA, SWEDEN,SWITZERLAND,TAIWAN, PROVINCE OF CHINA,TANZANIA, UNITED REPUBLIC OF,THAILAND,TRINIDAD AND TOBAGO, TUNISIA, TURKEY, TURKMENISTAN,UGANDA,UKRAINE,UNITED ARAB EMIRATES,UNITED KINGDOM,UZBEKISTAN,VENEZUELA,VIET NAM,YEMEN.
Product codes and lots: Model# Serial Numbers M3535A US00100100 to US00602546 M3535ATZ US00100100 to US00602546 M3536A US00100902 to US00602540 (M3536ATZ) US00100902 to US00602540 M3536M US00500002 to US00553553 M3536MC US00500001 to US00500087 M3536M2 US00554176 to US00554178 M3536M3 US00571854 to US00588995 M3536M4 US00500003 to US00590982 M3536M5 US00500001 to US00587771 M3536M6 US00554358 to US00600582 M3536M7 US00581047 to US00601962 M3536M8 US00590958 to US0059095 M3536M9 US00581048 to US00581049

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1417-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1417-2017	Class I	Terminated	Voluntary: Firm initiated	2017-04-05	2017-03-24

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)