Philips HeartStart XL Monitor/Defibrillators 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
FDA Recall Z-2137-2020 · Posted None
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Recalling FirmPhilips North America, LLC
Recall StatusTerminated
Product CodeMKJ
Date Initiated2020-04-21
Date Terminated2021-07-16
Product Quantity130 units (US 126; OUS 4)
Reason for Recall
HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections
Firm Action
Philips issued Urgent Medical Device Removal (FSNB6100215A) on 4/21/20 to U.S. customers via certified mail. Philips Markets Organizations are responsible for distributing the letters outside of the U.S. Letter states reason for recall, health risk and action to take:
Upon receipt of this notification, promptly locate the affected XL M4735A device
listed on page 3, Appendix A, of this notification and remove them from clinical
use immediately.
A Philips representative will contact you to confirm that each device has been
PHILIPS removed from service. Philips intends to take no further action beyond this notification as the XL is beyond its support life and is no longer serviceable.
If you need further information or support concerning this notification, please
contact your local Philips representative or call us at 1-800-722-9377.
Root Cause
Process control
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the states of KY, MA, ND, NY and the countries of United Kingdom, Bahrain.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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