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Terminated

Philips HeartStart MRx monitor/defibrillators Models: M3535A, M3536A, M3536M4, M3536M5, and 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

FDA Recall Z-1896-2012 · Posted 2012-06-27

Recalling FirmPhilips Healthcare Inc.
Recall StatusTerminated
Product CodeMKJ
Date Initiated2012-06-20
Date Terminated2017-03-16
Product Quantity2914 units

Reason for Recall

HeartStart MRx Unexpected Pads/Paddles ECG Failure

Firm Action

Philips issued an Urgent Voluntary Medical Device Correction/Field Safety Notice letter on June 20, 2012. The letter informs customers of the issue, identifies details (including models and software versions applicable) of units affected, gives instructions on actions to be taken until the correction is available, and identifies what action Philips plans to eliminate or remedy the issue. The letter states that a Philips Healthcare representative will contact customers to arrange for the replacement of the Power PCA in all the affected devices. Philips will complete the installation free of charge. For questions or support concerning this issue contact your local Philips representative at 1-800-722-9377.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution - US (nationwide) and the countries of: AUSTRALIA, AUSTRIA, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHINA, COLOMBIA, EL SALVADOR, ETHIOPIA, FRANCE, GERMANY, HONG KONG, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, KOREA, REPUBLIC OF, LEBANON, LIBYAN ARAB JAMAHIRIYA, MEXICO, MOROCCO, NETHERLANDS, NETHERLANDS ANTILLES, NICARAGUA, NORWAY, PERU, PHILIPPINES, POLAND, QATAR, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, and VIET NAM.

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.

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