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U.S. Department of Health and Human Services

Class 2 Device Recall HeartStart XL

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 Class 2 Device Recall HeartStart XLsee related information
Date Initiated by FirmOctober 03, 2019
Create DateDecember 05, 2019
Recall Status1 Terminated 3 on April 19, 2023
Recall NumberZ-0608-2020
Recall Event ID 84236
510(K)NumberK110825 
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
ProductHeartStart XL+ Defibrillator/Monitor, Model 861290
Code Information All Units, Model number 861290
Recalling Firm/
Manufacturer		 Philips North America, LLC
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information ContactPhilips Customer Services
800-722-9377
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionPhilips 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 in Commerce24,738 units
DistributionUS Nationwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MKJ
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