| Product Description | Model/Product Number | Stock Identifiers | Volume | Recall ID |
| (a) Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as "Lifeline AED" brand. | Model DDU-100A | (a) Software versions earlier than version 2.002 | 42,650 units total. | Z-0580-2007 |
| (b) Defibtech Sentry Semi-Automatic External Defibrilator (AED) sold as "ReviveR AED" brand. | Model DDU-100B | (b) Software versions earlier than version 2.002 | 42,650 units total. | Z-0581-2007 |
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AED Recalls
| Alert Details for #2007030190 (Released 3/13/2007 17:27 EDT) | |
| Description: | Update to RASMAS alert #2007030090 of 3/7/07 (Product ID Specified) Defibtech Sentry Semi-Automatic External Defibrilators (AED) |
|---|---|
| Manufacturer: | Defibtech, LLC, Guilford, CT |
| 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. |
| Analyst Comments: | Please click on the hyperlink and the attachment in the Links field to view notification details dated February 17, 2007. Contact Defibtech at Tel: 1-877-453-4507, Tel: 1-203-436-6654, Tel: 1-203-453-4507, or www.defibtech.com. |
| Alert Type: | Recall URGENT | Source Alert Type: | FDA Class I |
|---|---|---|---|
| Domain: | Biomedical Devices | Source Type: | FDA Enforcement Report |
| Distribution: | United States and Internationally | Source Date: | 03/14/2007 |
| Links: |
|---|
| http://www.fda.gov/po/enforceindex/2007enforce.html |
| Product Information |