Devices

HeartStart MRx Defibrillator/Monitor

Model / Serial
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
No
Distribution
Worldwide Distribution -- USA, Canada, Afghanistan, Argentina, Aruba, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bosnia & Herzegovina, Brazil, Bulgaria, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Mexico, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Norway, Oman, Panama, Papua, New Guinea, Peru, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudia Arabia, Serbia & Montenegro, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, and Venezuela.
Product Description
HeartStart MRx Defibrillator/Monitor, M3535A/M3536A || Is used 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 HeartStart MRx Defibrillator/Monitor

Manufacturer

Philips Healthcare Inc.

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

43 devices with a similar name

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Philips HeartStart MRx Defibrillator/Monitor

Model / Serial
Model: M3535A and M3536A, Affected: , Software version: F.03.06 and T.00.05 and earlier
Manufacturer
Philips Medical Systems (USA)

HeartStart MRx Defibrillator/Monitor with software versions F.03.06 and T.00.05

Model / Serial
Units Affected: MRx unit types with software versions F.03.06 (M3535A) and T.00.05 (M3536A) and earlier and the following part numbers: PMS Number: 861288 Part Number: M3535A PMS Number: 989803132391 Part Number: M3535ATZ PMS Number: 861289 Part Number: M3536A PMS Number: 989803132401 Part Number: M3536ATZ PMS Number: 861314 Part Number: M3536J PMS Number: 861464 Part Number: M3536M PMS Number: 861481 Part Number: M3536M2 PMS Number: 861483 Part Number: M3536M4 PMS Number: 861484 Part Number: M3536M5 PMS Number: 861491 Part Number: M3536M6 PMS Number: 861465 Part Number: M3536MC
Product Description
Defibrillator/Monitor
Manufacturer
Philips Healthcare

HeartStart MRx Defibrillator/Monitor

Model / Serial
Product: Philips HeartStart MRx Lithium Ion batteries Model: M3538A serial numbers: 11327-0019-P, 11315-0023-P, 11315-0027-P, 11315-0031-P, 11315-0032-P, 11315-0033-P, 11315-0036-P, 11315-0109-P, 11315-0214-P, 11315-0219-P, 11315-0391-P, 11322-0084-P, 11322-0088-P, 11327-0043-P, 11327-0044-P Or within the following range: 11335-xxxx-P to 13214-xxxx-P
Product Description
Monitor, Defibrillator, Lithium Ion batteries
Manufacturer
Philips Healthcare

certain HeartStart MRx defibrillator/monitors

Model / Serial
Product Description
Medical electronics / Electromedical devices - electrotherapy
Manufacturer
Philips Healthcare

Philips HeartStart MRx Defibrillator/Monitor

Model / Serial
Manufacturer
Philips Healthcare

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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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