Philips Medical Systems, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1194-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with Q-CPR Meter Option B08 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

Product Classification:

Class II

Date Initiated: February 18, 2014

Date Posted: March 19, 2014

Recall Number: Z-1194-2014

Event ID: 67459

Reason for Recall:

When the HeartStart MRx.is used with the Q-CPR Meter in defibrillation mode, the Q-CPR Meter may incorrectly display the Do Not Touch the Patient icon.

Status: Terminated

Product Quantity: 6583 units

Code Information:

MRx units with the Q-CPR Meter option B08 and with a serial number within the range: US00100253 and US00571587

Distribution Pattern:

Worldwide distribution: US (nationwide) and to countries of: ARUBA AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA ECUADOR EGYPT FINLAND FRANCE GERMANY HONG KONG INDIA INDONESIA IRELAND ISRAEL ITALY KENYA KOREA, REPUBLIC OF KUWAIT LATVIA LIBYAN ARAB JAMAHIRIYA MALAYSIA MEXICO MOROCCO NETHERLANDS NORWAY OMAN PAKISTAN PHILIPPINES POLAND QATAR RUSSIAN FEDERATION SAUDI ARABIA SINGAPORE SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TAIWAN, PROVINCE OF CHINA THAILAND TURKEY UKRAINE UNITED ARAB EMIRATES and UNITED KINGDOM.

Voluntary or Mandated:

Voluntary: Firm initiated