Recall Z-1312-2023 ยท MKJ Automated External Defibrillators (Non-Wearable)
Defibtech, LLC
DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest
| Date | Mar 30, 2023 (initiated Feb 14, 2023) |
| Status | Open, Classified |
| Reason | A component of a sub-assembly used in the affected AEDs had not undergone durability and reliability testing, and if a malfunction occurs, therefore the device could fail to deliver therapy. |
| Root cause | Device Design |
| Action | Defibtech issued Urgent Medical Device Safety Removal User letter (FA2023-01) on 2/14/23 and 2/17/23 via email to Distributors and End-Users. Letter states reason for recall, health risk and action to take: 1. Confirm receipt of this notice by checking the Read receipt option in the email notification containing this communication. Additionally, complete, sign and return to FA2023@defibtech.com the attached Receipt Letter acknowledging that you have received this recall notification 2. Check the box label s 9-digit serial number of any units in your inventory against the serial numbers liste |
| Quantity | 29 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.