Philips North America, LLC Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: 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.
Brand
Philips North America, LLC
Lot Codes / Batch Numbers
All units. Product has been discontinued.
Products Sold
All units. Product has been discontinued.
Philips North America, LLC is recalling Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the due to The rotary therapy selector switch may fail, resulting in unexpected device behavior including: 1) The device may not turn on; 2) The device may not p. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The rotary therapy selector switch may fail, resulting in unexpected device behavior including: 1) The device may not turn on; 2) The device may not perform the selected function;3) The device may deliver a shock with an energy level different than the setting selected by the user. In any of these scenarios, appropriate therapy delivery may be delayed.
Recommended Action
Per FDA guidance
On April 13, 2020, the firm distributed URGENT Medical Device Recall letters to affected customers. Customers were informed of the device defect, which may result in the following unexpected behavior: - The device may not turn on. - The device may not perform the selected function. - The device may deliver a shock with an energy level different from the setting selected by the user. There have been three reported patient deaths potentially associated with the failure of the HeartStart XL Monitor/Defibrillator rotary therapy selector switch. Customers were advised that the HeartStart XL Defibrillator/Monitor has been discontinued and has reached its end of life. Therefore, custoemrs should replace and retire their units as soon as practically possible. Customers should continue to perform Shift Checks and Operational checks as recommended in the Instructions for Use (IFU) as this reduces the risk of a failure until your units are safely retired. If you identify a device that exhibits any of the behaviors described above, or which fails shift or operational checks, immediately remove it from service. Customers were asked to complete and fax or email the included customer reply form to Philips. If you need further information or support concerning this notification, please contact your local Philips representative or call us at 1-800-722-9377.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026