Recall Z-2393-2020 ยท MKJ Automated External Defibrillators (Non-Wearable)
Defibtech, LLC
DDU-2400EN Lifeline PRO, UDI 00815098020270 - Product Usage: Automated External Defibrillators (AED) are indicated for use on victims of sudden cardiac arrest (SCA) who are: - unconscious and unresponsive, not breathing or not breathing normally.
| Date | Apr 27, 2020 |
| Status | Terminated |
| Reason | A component issue may cause the AED to abort a shock delivery or reset unexpectedly, which may cause an affected device to fail to delivery shock, and/or to fail to deliver shock in range. |
| Root cause | Component design/selection |
| Action | The firm contacted affected customers via email and mailed letter on April 27, 2020. Distributors were asked to forward letters to end users. Customers were informed that affected products may abort a shock delivery or reset unexpectedly. Customers were asked to return all affected products for screening. Actions to be taken by the Customer/User: 1. If you have additional AEDs on hand , please quarantine and return any affected units as identified in the Attachment for screening or replacement. Do not include the pads and battery packs when you return your unit. 2. If no other AEDs are avail |
| Quantity | 860 |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada, France, Malaysia, Mauritius, Netherlands, Thailand, United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.