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Terminated

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

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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