Recall Z-0581-2007 ยท MKJ Automated External Defibrillators (Non-Wearable)
Defibtech, LLC
Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as 'ReviveR AED' brand -Model DDU-100B (version 2.002 and earlier)
| Date | Mar 8, 2007 (initiated Feb 17, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 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 Em |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.