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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 XL see related information
Date Initiated by Firm October 03, 2019
Create Date December 05, 2019
Recall Status1 Terminated 3 on April 19, 2023
Recall Number Z-0608-2020
Recall Event ID 84236
510(K)Number K110825  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product HeartStart 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 Contact Philips 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
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 in Commerce 24,738 units
Distribution US Nationwide
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS
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