Philips North America, LLC HeartStart XL+ Defibrillator/Monitor, Model 861290 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HeartStart XL+ Defibrillator/Monitor, Model 861290
Brand
Philips North America, LLC
Lot Codes / Batch Numbers
All Units, Model number 861290
Products Sold
All Units, Model number 861290
Philips North America, LLC is recalling HeartStart XL+ Defibrillator/Monitor, Model 861290 due to 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 oc. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026