Devices

Device Recall HEARTSTART MRX, MODEL M3535A

Model / Serial
Serial numbers within the following range. US00533518 through US00535118.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
No
Distribution
Nationwide Canada Australia, Austria, Beharin, BRUNEI DARUSSALAM,Chian,. Finland, France, Germany,Hong Kong, India, Indonesia, Ireland, Israel,Italy, Japan, Libya, Lithuania. Mexico, Nambia, Netherlands, Palestine, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, UAE, UK
Product Description
HeartStart MRx (M3535A/M3536A) Defibrillator/Monitor. || The HeartStart MRx/MRxE 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 basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
Manufacturer
Philips Healthcare Inc.
1 Event
- Recall of Device Recall HEARTSTART MRX, MODEL M3535A

Manufacturer

Philips Healthcare Inc.

Manufacturer Address
Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
Manufacturer Parent Company (2017)
Philips
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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