Recall Z-0011-2013— Philips Healthcare Inc.
Class II · Terminated
Class II FDA medical device recall by Philips Healthcare Inc., initiated 2012-09-11, terminated 2020-08-27. It names one FDA 510(k) clearance: K021453. Product: Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL Defibrillator/Monitor is a fully featured, defibrillator intended for use by qualified medical personnel, trained in either Advanced Cardiac Life Support or in the operation of the device, in a hospital environment.. Reason: HeartStart XL Defibrillator/Monitor (M4735A) used on a patient when AC power is not in use, with a battery that may fail, the device may shut down unexpectedly without providing the user with a low battery warning message or audible tone..
- Recalling firm
- Philips Healthcare Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-09-11
- Terminated
- 2020-08-27
- Firm location
- Andover, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL Defibrillator/Monitor is a fully featured, defibrillator intended for use by qualified medical personnel, trained in either Advanced Cardiac Life Support or in the operation of the device, in a hospital environment.
Reason for recall
HeartStart XL Defibrillator/Monitor (M4735A) used on a patient when AC power is not in use, with a battery that may fail, the device may shut down unexpectedly without providing the user with a low battery warning message or audible tone.
Data sourced from openFDA. This site is unofficial and independent of the FDA.