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Terminated

HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J 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-1120-2014 · Posted 2014-02-26

Recall StatusTerminated
Product CodeMKJ
Date Initiated2014-02-18
Date Terminated2020-09-03
Product Quantity43,792 batteries

Reason for Recall

Philips HeartStart MRx Monitor/Defibrillator, when operating on battery power only, may experience an unexpected shutdown if exposed to elevated levels of electromagnetic interference from RF energy source

Firm Action

The firm, Philips Healthcare, sent an "URGENT- Medical Device Correction" letter dated February 2014 and issued a Field Safety Notice on February 18/ 2014 to its customers. The letter and 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. Philips will replace the affected batteries free of charge. Philips instructed customers to follow the Action to be Taken by Customer/User section of the Field Safety Notice. Fixed, portable, and mobile radio frequency communications equipment can affect the performance of medical equipment. See the HeartStart MRx Instructions for Use for the minimum recommended separation distance between RF communications equipment and the HeartStart MRx. The condition can be avoided by operating the device on AC or external DC power or by the following actions when operating on battery. If you need any further information or support concerning this issue, please contact your local Philips representative or call us at 1-800-722-9377.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution: US (nationwide) and Internationally to: ALBANIA, ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BELGUIM, BOLIVIA, BRAZIL, CANADA, CHINA, COLOMBIA, CONGO, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, EL SALVADOR, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GERMANY, HONG KONG, ICELAND, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA REPUBLIC, KUWAIT, LATIVA, LEBANON, LIBYAN ARAB, LITHUANIA, MALAYSIA, MALTA, MEXICO, MONGOLIA, MOROCCO, MOZAMBIQUE, MYANMAR, NEPAL, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIAN FEDERAL, SAUDIA ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN PROVIDENCE, THAILAND, TRINIDAND AND TABAGO, TUNISIA, TURKEY, TURKMENISTANIA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, and VIETNAM.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

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