FDAFDA · Food and drugs·Recall number Z-1120-2014
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
Published March 5, 2014 · Recall initiated: February 18, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Medical Systems, Inc.
- Distributor
- 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.
- Lot
- Serial numbers: 11327-0019-P 11315-0023-P 11315-0027-P 11315-0031-P 11315-0032-P 11315-0033-P 11315-0036-P 11315-0109-P 11315-0214-P 11315-0219-P 11315-0391-P 11322-0084-P 11322-0088-P 11327-0043-P 11327-0044-P Or within the following range: 11335-xxxx-P to 13214-xxxx-P
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.