HeartStart XL+ Defibrillator/Monitor, Model 861290
FDA Recall Z-0608-2020 · Posted None
Recalling FirmPhilips North America, LLC
Recall StatusTerminated
Product CodeMKJ
Date Initiated2019-10-03
Date Terminated2023-04-19
Product Quantity24,738 units
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
US Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.