Recall Z-0581-2007
Defibtech, LLC · initiated February 17, 2007
Product
Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as 'ReviveR AED' brand -Model DDU-100B (version 2.002 and earlier)
Codes / lots: Software versions earlier than version 2.002
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: Software design
Action taken
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
Details
- Recall number
- Z-0581-2007
- Initiated
- February 17, 2007
- Posted by FDA
- March 8, 2007
- Terminated
- June 9, 2021
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
- Quantity
- 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.
- Recalling firm
- Defibtech, LLC, Guilford, CT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0580-2007 | Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as 'Lifeline AED' brand…Device Malfunction-The self-test software may allow a self-test to clear a previously detected low battery… | 02/17/2007Terminated |