Devices

Device Recall Phillips HeartStart MRx Monitor/Defribillator

Model / Serial
MRx units with the Q-CPR Meter option B08 and with a serial number within the range: US00100253 and US00571587
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
No
Distribution
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.
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
Manufacturer
Philips Medical Systems, Inc.
1 Event
- Recall of Device Recall Phillips HeartStart MRx Monitor/Defribillator

Manufacturer

Philips Medical Systems, Inc.

Manufacturer Address
Philips Medical Systems, Inc., 3000 Minuteman Rd, Andover MA 01810-1032
Manufacturer Parent Company (2017)
Philips
Source
USFDA

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