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 1 Device Recall ReviveR AEDDefibtech Sentry

  • 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 1 Device Recall ReviveR AEDDefibtech Sentry see related information
Date Initiated by Firm February 17, 2007
Date Posted March 08, 2007
Recall Status1 Terminated 3 on June 09, 2021
Recall Number Z-0581-2007
Recall Event ID 37394
Product Classification Semi-Automatic External Defibrilator - Product Code MKJ
Product Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as 'ReviveR AED' brand -Model DDU-100B (version 2.002 and earlier)
Code Information Software versions earlier than version 2.002
Recalling Firm/
Manufacturer		 Defibtech, LLC
741 Boston Post Rd Ste 201
Guilford CT 06437-2714
For Additional Information Contact Brian Swan
203-436-6654 Ext. 11
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.
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 14, 022
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
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.
-
-