Devices

Device Recall XL Defibrillator

Model / Serial
HeartStart XL+ Defibrillator/Monitor,All Chinese XL manufactured before September, 2017, unless the XL+ is affected by F5N86100172, and has not been updated.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
No
Distribution
Foreign Only - China
Product Description
HeartStart XL+ Defibrillator/Monitor || The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support, or defibrillation. It must be used by or on the order of a physician. When operating as a semi-automatic external defibrillator in AED Mode, the HeartStart XL+ is suitable for use by medical personnel trained in basic life support that includes use of an AED. When operating in Monitor, Manual Defib, or Pacer Mode, the HeartStart XL+ is suitable for use by healthcare professionals trained in advanced life support.
Manufacturer
Philips Electronics North America Corporation
1 Event
- Recall of Device Recall XL Defibrillator

Manufacturer

Philips Electronics North America Corporation

Manufacturer Address
Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
Manufacturer Parent Company (2017)
Philips
Source
USFDA

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