Skip to content
Recall Observatory FDA recall evidence

Device product

Philips HeartStart XL, Defibrillator/Monitor Model number M4735A Product Usage: The M4735A HeartStart XL Defibrillator/Monitor is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac 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 M4735A HeartStart XL Defibrillator/Monitor is suitable for use by medical personnel trained in basic life support that includes the use of an AED

Z-1109-2014

February 14, 2014

Class II

Product summary

Firm
Philips Medical Systems, Inc.
Event
Event 67483
Status
Terminated
Classification
Class II
Quantity
5234 units
Official record key
device-enforcement:Z-1109-2014

Official wording

Reason: Philips HeartStart XL may experience a power board failure causing failure to defibrillate

Code information: Serial numbers within the range: US00101665 through US00608704 Units manufactured by Philips between May, 2013 and November, 2013.

Distribution pattern: Worldwide Distribution and USA Nationwide and the countries of AUSTRALIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, ETHIOPIA, FINLAND, FRANCE, GEORGIA, GERMANY, HUNGARY, INDIA, INDONESIA, IRELAND, ITALY, JAPAN, KAZAKHSTAN, KOREA, REPUBLIC OF, MALAYSIA, MEXICO, MONACO, NEPAL, NETHERLANDS, PORTUGAL, SINGAPORE, SOUTH AFRICA, SPAIN, SRI LANKA, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, and VIET NAM,

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Philips HeartStart XL may experience a power board failure causing failure to defibrillate