Z-0322-2011

HeartStart MRx Defibrillator/Monitor Models: M3535A / M3536A / M3536J / M3536MC The HeartStart MRx is for use...

Name: Z-0322-2011 HeartStart MRx Defibrillator/Monitor Models: M3535A / M3536A / M3536J / M3536MC The HeartStart MRx is for use...
Creator: Philips Healthcare Inc.
Published: 2010-07-16
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2010-07-16 / Terminated / root cause: labeling and UDI

FDA source

Philips Healthcare Inc. began a recall of HeartStart MRx Defibrillator/Monitor Models: M3535A / M3536A / M3536J / M3536MC The HeartStart MRx is for use for the termination of ventricular tachycardia... on 2010-07-16. The reason FDA records is "Updated Instructions for Use- HeartStart MRx monitor/defibrillator. The update provides more detailed information on: " Default ECG Lead Behavior " Synchronized Cardioversion using External Paddles". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0322-2011
Status: Terminated
Initiated: 2010-07-16
Posted: 2010-11-08
Terminated: 2012-09-05
Recalling firm: Philips North America LLC
Product: HeartStart MRx Defibrillator/Monitor Models: M3535A / M3536A / M3536J / M3536MC The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Updated Instructions for Use- HeartStart MRx monitor/defibrillator. The update provides more detailed information on: " Default ECG Lead Behavior " Synchronized Cardioversion using External Paddles
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Philips issued an Urgent Voluntary Medical Device Correction notification/Field Safety Notice and an Instructions for Use Addendum on July 20, 2010, to affected customers. The Notice identified the product, the problem, and the action customers should take. In the USA, the notification sent to all affected customers via UPS and confirmation of delivery would be tracked. Outside the USA, Philips representatives in the affected geographies would manage their mailings locally. Customers were instructed to review the HeartStart MRx Instructions for Use addendum and keep a copy with their equipment - Instructions for Use. Additionally, they were instructed to insure that all users are fully trained on the MRx and, in particular, ensure that they review and understand have reviewed and understand the additional detail provided in the notification. For questions regarding this recall call (800) 722-9377.
Quantity in commerce: 41,119 units
Distribution: Worldwide Distribution - US Nationwide and the countries of: CANADA AFGHANISTAN ALBANIA ARGENTINA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BELGIUM BOSNIA&HERZEGOVINA BRAZIL BRUNEI DARUSSALAM BULGARIA CHILE CHINA COLOMBIA CYPRUS CZECH REPUBLIC DENMARK ECUADOR EGYPT ESTONIA FINLAND FRANCE GERMANY GREECE GUADELOUPE HONG KONG HUNGARY ICELAND INDIA INDONESIA IRELAND ISRAEL ITALY JAPAN JORDAN KENYA KUWAIT LATVIA LEBANON LIBYAN ARAB JAMAHIRI LITHUANIA LUXEMBOURG MACEDONIA MALAYSIA MEXICO MOROCCO NAMIBIA NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NICARAGUA NORWAY OMAN PAKISTAN PALESTINE PANAMA PAPUA NEW GUINEA PERU PHILIPPINES POLAND PORTUGAL PUERTO RICO QATAR REUNION ROMANIA RUSSIA SAUDI ARABIA SERBIA&MONTE NEGRO SINGAPORE SLOVENIA SOUTH AFRICA SOUTH KOREA SPAIN SRI LANKA SWEDEN SWITZERLAND TAIWAN THAILAND TRINIDAD AND TOBAGO TUNISIA TURKEY UGANDA UKRAINE UNITED ARAB EMIRATES UNITED KINGDOM VENEZUELA VIET NAM YEMEN
Product codes and lots: This action affects all customers who were shipped an MRx unit from 2/11/2004 through 06/25/2010

Product code MKJ

K051137Class IITechdevice Occlusion Balloon CatheterTechdevice Corporation / cleared 2006-02-24

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)