Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as 'Lifeline AED' brand -Model DDU-100A (version 2.002 and earlier)
FDA Recall Z-0580-2007 · Posted 2007-03-08
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Recalling FirmDefibtech, LLC
Recall StatusTerminated
Product CodeMKJ
Date Initiated2007-02-17
Date Terminated2021-06-09
Product Quantity22,197 units
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.
Firm 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
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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