Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Lifeline PRO

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Lifeline PRO see related information
Date Initiated by Firm April 27, 2020
Create Date June 17, 2020
Recall Status1 Terminated 3 on January 08, 2021
Recall Number Z-2393-2020
Recall Event ID 85702
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product DDU-2400EN Lifeline PRO, UDI 00815098020270 - Product Usage: Automated External Defibrillators (AED) are indicated for use on victims of sudden cardiac arrest (SCA) who are: - unconscious and unresponsive, not breathing or not breathing normally.
Code Information Serial Number 400101322 
Recalling Firm/
Manufacturer		 Defibtech, LLC
741 Boston Post Rd
Suite 201
Guilford CT 06437-2714
For Additional Information Contact Defibtech Customer Service
203-453-6654 Ext. 2
Manufacturer Reason
for Recall		 A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to fail to deliver shock in range.
FDA Determined
Cause 2		 Component design/selection
Action The firm contacted affected customers via email and mailed letter on April 27, 2020. Distributors were asked to forward letters to end users. Customers were informed that affected products may abort a shock delivery or reset unexpectedly. Customers were asked to return all affected products for screening. Actions to be taken by the Customer/User: 1. If you have additional AEDs on hand , please quarantine and return any affected units as identified in the Attachment for screening or replacement. Do not include the pads and battery packs when you return your unit. 2. If no other AEDs are available, please continue using the device with caution until a loaner or replacement is provided. 3. Ensure that all users of the AED are informed of the product issue. Defibtech will provide support for handling all aspects of the return of identified units for screening. The firm will contact customers to help them with the process. If you have questions now, please contact the firm using the email address FA2020@defibtech.com. Additionally, Defibtech Customer Support is available by calling 1-877-453-4507, 8:30 A.M. to 5:30 P.M. (Eastern), Monday - Friday.
Quantity in Commerce 860
Distribution Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada, France, Malaysia, Mauritius, Netherlands, Thailand, United Arab Emirates.
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.
-
-