FDA Medical Device Recalls (openFDA)
Philips Medical Systems, Inc.: 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
- Recall number
- Z-1109-2014
- Recalling firm
- Philips Medical Systems, Inc.
- 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
- Status
- Terminated
- Initiated
- 2014-02-14
- Posted
- 2014-02-26
- Terminated
- 2016-06-16
- Reason
- Philips HeartStart XL may experience a power board failure causing failure to defibrillate
- Root cause
- Component design/selection
- Action
- Philips Healthcare issued an Urgent Medical Device Correction notification/Field Safety Notice dated February 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were informed Philips Healthcare Representative will perform a hardware upgrade free of charge. Customers were instructed while awaiting the replacement power board for your device, you may continue to use the HeartStart XL. Identify a readily available backup defibrillator to use in the event the affected HeartStart XL fails to deliver therapy. If you need any further information or support concerning this issue, please contact your local Philips representative at 1-800-722-9377
- Quantity
- 5234 units
- Distribution
- 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,
- Lot, serial or model codes
- Serial numbers within the range: US00101665 through US00608704 Units manufactured by Philips between May, 2013 and November, 2013.
- 510(k) numbers
- ["K051134"]
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28