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
Recall
- Recall Number
- Z-2137-2020
- Event Number
- 85580
- Firm
- Philips North America, LLC
- FEI Number
- 1218950
- Product Code
- MKJ
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- April 21, 2020
- Terminated
- July 16, 2021
- Address
- 3000 Minuteman Rd, Andover, MA, 01810-1032
Description
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
HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections
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.
Worldwide distribution - US Nationwide distribution including in the states of KY, MA, ND, NY and the countries of United Kingdom, Bahrain.
130 units (US 126; OUS 4)