HeartStart MRx monitor/defibrillator Models M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: 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
This recall has been terminated (originally issued November 5, 2015).
- Company
- Philips Medical Systems, Inc.
- Recall Initiated
- December 23, 2014
- Posted
- November 5, 2015
- Terminated
- September 9, 2020
- Recall Number
- Z-0219-2016
- Quantity
- 75,693 units
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
MRx monitor/defibrillator could reboot at an indeterminate time, potentially causing therapy to be interrupted or delayed
Distribution
Worldwide Distribution - US Nationwide and the countries of AFGHANISTAN, ALBANIA, ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA AND HERZEGOWINA, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CAMBODIA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA (local name: Hrvatska), CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GERMANY, GHANA, GREECE, GUADELOUPE, HONG KONG, ICELAND, INDIA, INDONESIA, IRAN (ISLAMIC REPUBLIC OF), IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, Jordan, KAZAKHSTAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LAOS, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MACAU, MACEDONIA, MALAYSIA, MALTA, MEXICO, MONGOLIA, MOROCCO, MOZAMBIQUE, MYANMAR (Burma), NAMIBIA, NEPAL, NETHERLANDS, NETHERLANDS ANTILLES, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PALESTINE, PANAMA, PAPUA NEW GUINEA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, UNITED REPUBLIC OF TANZANIA, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, TURKMENISTAN, UGANDA, UKRAINE, UNITED ARAB EMIRATES, and UNITED KINGDOM.
Lot / Code Info
Model/Serial Number Range: Model M3535A: US00100100 to US00578696 Model M3536A: US00100902 to US00576650 Model M3536J: US00209838 to US00332675 Model M3536M: US00500002 to US00553553 Model M3536MC: US00500001 to US00500087 Model M3536M2: US00554176, US00554177, US00554178 Model M3536M4: US00500003 to US00574869 Model M3536M5: US00500001 to US00562935 Model M3536M6: US00554358 to US00576619
Root Cause
Software design
Action Taken
Philips Healthcare issued on 12/23/14 The Urgent Medical Device Correction notification/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. A software upgrade will be provided free of charge for all units affected by one or more of these issues. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the upgrade. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice: You can continue to use your MRx prior to receiving the software upgrade. If the MRx reboots during clinical use, continue to treat the patient according to your organizations protocol, reinitiating therapy if necessary.