HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion recall
HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J The HeartStart MRx is for use for the termination of ventricular…
Why was HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J The HeartStart MRx is for use for the termination of ventricular…
- Recalling firm
- Philips Medical Systems, Inc.
- Quantity
- 43,792 batteries
- Distribution
- 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.
- Recall date
- March 5, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)