HeartStart XL+ Defibrillator/Monitor, Model 861290
This recall has been terminated (originally issued October 3, 2019).
- Company
- Philips North America, Llc
- Recall Initiated
- October 3, 2019
- Terminated
- April 19, 2023
- Recall Number
- Z-0608-2020
- Quantity
- 24,738 units
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Device may fail to turn on or unexpectedly attempt to restart, rendering it unable to return to a ready for use state. Additionally, this issue may occur when the device is in standby mode, when attempting to power on to run a self-test. If this occurs, the device will indicate that it is not ready for use.
Distribution
US Nationwide
Lot / Code Info
All Units, Model number 861290
Root Cause
Process control
Action Taken
Philips Healthcare issued Medical Device Correction Notices dated 10/3/2019 to customers via certified mail. Customers are advised to take the following actions: - The device is safe to use and can remain in service if it does not exhibit any of these behaviors described in this notice. - If you identify a device that exhibit these behaviors, please remove the device from service and contact Philips to request device. - Fill out, sign and send the reply form that is provided as the last page of the letter.