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Class 1 Device Recall Lifeline AEDDefibtech Sentry |
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Date Initiated by Firm |
February 17, 2007 |
Date Posted |
March 08, 2007 |
Recall Status1 |
Terminated 3 on June 09, 2021 |
Recall Number |
Z-0580-2007 |
Recall Event ID |
37394 |
510(K)Number |
K013896
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Product Classification |
Semi-Automatic External Defibrilator - Product Code MKJ
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Product |
Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as 'Lifeline AED' brand -Model DDU-100A (version 2.002 and earlier) |
Code Information |
Model DDU 100A-Software versions earlier than version 2.002 |
Recalling Firm/ Manufacturer |
Defibtech, LLC 741 Boston Post Rd Ste 201 Guilford CT 06437-2714
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For Additional Information Contact |
Brian Swan 203-436-6654 Ext. 11
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Manufacturer Reason for Recall |
Device Malfunction-The self-test software may allow a self-test to clear a previously detected low battery condition. If this occurs, the operator may be unaware of the low battery and the device may be "unable" to deliver a defibrillation shock, which could result in failure to resuscitate a patient.
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FDA Determined Cause 2 |
Software design |
Action |
Defibtech LLC initiated notification to customers/distributors on 2/17/07 by email. Hard copy letters followed on 2/22/07 with acknowledgement card. Users provided with instructions for 'Immediate Recommendations' until the unit''s software is upgraded.
Distributors, their customers, and direct accounts instructed to locate affected units and upgrade these units in the field. Distributors, their
customers, and direct accounts shall return to Defibtech documentation confirming unit
software upgrade was completed..Press was issued by the firm on March 6, 2007 |
Quantity in Commerce |
22,197 units |
Distribution |
Worldwide distribution ---- USA and countries of Canada, Uruguay, Jordon, Turkey United Kingdom, Saudi Arabia, Sweden France, South Africa, Cyprus, Spain, Germany India, Japan, Israel, Australia, Norway, Philppines Singapore, Poland, Germany, Italy, Switzerland Netherlands, Indonesia, United Arab Emirates Malaysia, Austria, Ireland, Kingdom of Bahrain, and Korea. |
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 and Original Applicant = DEFIBTECH, LLC
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