| Class 1 Device Recall Lifeline AED DDU100 semiautomatic external defibrillator used with the DBP2800 Battery Pack | |
Date Initiated by Firm | May 21, 2010 |
Date Posted | June 10, 2010 |
Recall Status1 |
Terminated 3 on September 29, 2020 |
Recall Number | Z-1781-2010 |
Recall Event ID |
55497 |
510(K)Number | K013896 |
Product Classification |
Automated external defibrillators (non-wearable) - Product Code MKJ
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Product | Lifeline AED DDU-100 semiautomatic external defibrillator used with the DBP-2800 Battery Pack, Manufactured by Defibtech, LLC. Seymour, CT 06483.
The DBP-2800 battery pack is an accessory to the AED and does not have its own intended use. The AED is intended for use on victims of sudden cardiac arrest when the patient is unconscious, unresponsive and not breathing. |
Code Information |
Serial Numbers range from 202001005 through 202005916 and 206001001 through 206009871. |
Recalling Firm/ Manufacturer |
Defibtech LLC 4 Progress Ave Seymour CT 06483-3921
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For Additional Information Contact | Al Raebuck 203-453-6654 Ext. 122 |
Manufacturer Reason for Recall | The AED when used with an affected battery pack, may falsely detect an error condition, cancel charge and not provide therapy |
FDA Determined Cause 2 | Device Design |
Action | Defibtech, LLC issued an "Urgent Medical Device Safety Information and Correction" notification dated May 20, 2010 by email and hard copy via US Mail. The notification instructed Consignees on proper identification of affected product and steps to take for product replacement.
For further information, contact your distributor or Defibtech Technical Support at techsupport@defibtech.com or call 1-877-453-4507 or 1-203-453-4507, 8:30 AM to 5:00 PM Monday - Friday, EST. |
Distribution | Worldwide Distribution -- United States, Canada, Australia, Jordan, Spain, Israel, UK, Poland, Italy, Netherlands, Malaysia and Ireland. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = MKJ
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