Recall Z-0608-2020 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips North America, LLC
HeartStart XL+ Defibrillator/Monitor, Model 861290
| Date | Oct 3, 2019 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 24,738 units |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110825 | PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRODES Philips Medical Systems, Feb 16, 2012 |