Recall Z-2137-2020— Philips North America, LLC
Class II · Terminated
Class II FDA medical device recall by Philips North America, LLC, initiated 2020-04-21, terminated 2021-07-16. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections.
- Recalling firm
- Philips North America, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-04-21
- Terminated
- 2021-07-16
- Firm location
- Andover, MA, United States
Product 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
Reason for recall
HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections
Data sourced from openFDA. This site is unofficial and independent of the FDA.