Philips Medical Systems, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1109-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 14, 2014

Date Posted: March 5, 2014

Recall Number: Z-1109-2014

Event ID: 67483

Reason for Recall:

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

Status: Terminated

Product Quantity: 5234 units

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,

Voluntary or Mandated:

Voluntary: Firm initiated