Terminated

HeartStart MRx Defibrillator Monitor (Models M3535A, M3536A and M3536J) used with Philips 14.8-Volt Lithium Ion Battery (ModeI M3538A). 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.

FDA Recall Z-1317-2010 · Posted 2010-04-09

Recalling FirmPhilips Healthcare Inc.

Recall StatusTerminated

Product CodeMKJ

Date Initiated2010-03-04

Date Terminated2017-02-15

Product Quantity37,674 units

Reason for Recall

Batteries older than 2 years have a higher potential for intermittent electrical contact, may contribute to an interruption in monitoring or therapy if the monitor/defibrillator is operating on battery.

Firm Action

An "Urgent Medical Device Correction" letter with a Field Safety Notice was issued on March 4, 2010 to affected customers. The Instructions for Use Addendum/Application Note is included with the communication describing when to replace the unit's 14.8-Volt Lithium Ion Battery (Product #M3538A) Number M3538A in the the Philips HeartStart MRx Monitor/Defibrillator. Should you have any questions or concerns about the Device Correction, please contact your local Philips representative.

Root Cause

Component design/selection

Distribution Pattern

Worldwide: UNITED STATES, CANADA, AFGHANISTAN, ALBANIA, ,ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELGIUM BOSNIA&HERZEGOVINA, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, FRANCE, GERMANY, GREECE, GUADELOUPE, HONG KONG, ICELAND, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRI, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, NAMIBIA, NETHERLANDS, NETHERLANDS ANTILLES, NETHERLANDS ANTILLES, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PALAU, PANAMA, PAPUA NEW GUINEA, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, 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, VIETNAM and YEMEN.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051134HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536APhilips Medical Systems · 2005-09-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.