—#180169

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.

FDA product code: MKJ — Automated External Defibrillators (Non-Wearable)
Device class: Class 3
Medical specialty: Cardiovascular
510(k) numbers: K001725
Affected lot / code info: All units. Product has been discontinued.

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Philips North America, LLC
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: Worldwide distribution - US Nationwide distribution.

Timeline

Recall initiated: 2020-04-13
Terminated: 2021-04-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180169. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.