FDA Device recall Z-2392-2020
DDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A2300EN, DDU-E2300EN Catalog Numbers CCD-A1006RX CCD-A1013EN CC…
- FDA Device
- Class II
- terminated
- Published 2020-06-24
On 2020-06-24 the FDA classified a Class II recall of DDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A2300EN, DDU-E2300EN Catalog Numbers CCD-A1006RX CCD-A1013EN CC… by Defibtech, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2392-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-27 |
| Published | 2020-06-24 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Defibtech |
| Distribution | US |
Product
DDU-2300 Lifeline/ReviveR View, Model Numbers DDU-C2300EN, DDU-C2300CA, DDU-A2300EN, DDU-E2300EN Catalog Numbers CCD-A1006RX CCD-A1013EN CCD-A1015EN DCF-A2310EN DCF-A2310RX DCF-A2313EN DCF-C2310CA DCF-C2310EN DCF-E2310CA DCF-E2310EN UDI 00815098020201, 00815098020225, 00815098020232 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.
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.
Identifiers
| code_info | Serial Numbers: 400086354 400086358 400090005 400091761 400093477 400093478 400093479 400093480 400093481 400…Serial Numbers: 400086354 400086358 400090005 400091761 400093477 400093478 400093479 400093480 400093481 400093482 400093483 400093484 400093485 400093486 400093487 400093488 400093489 400093490 400093491 400093492 400093493 400093494 400093495 400093496 400093497 400093498 400093499 400093500 400093501 400093502 400093503 400093504 400093505 400093506 400093508 400093510 400093512 400093513 400093514 400093515 400093516 400093517 400093518 400093519 400093520 400093521 400093522 400093523 400093524 400093525 400093527 400093528 400093529 400093530 400093531 400093532 400093533 400093534 400093535 400093536 400093538 400093539 400093540 400093541 400093542 400093543 400093544 400093545 400093546 400093547 400093548 400093549 400093550 400093551 400093552 400093553 400093554 400093555 400093556 400093557 400094155 400098786 400098812 400101171 400101172 400101174 400101175 400101176 400101177 4001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2392-2020%22
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