Recall Z-1693-2025 ยท MKJ Automated External Defibrillators (Non-Wearable)
Defibtech, LLC
Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language)
| Date | Apr 29, 2025 (initiated Mar 18, 2025) |
| Status | Open, Classified |
| Reason | It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian). |
| Root cause | Process control |
| Action | On March 18, 2025 URGENT FIELD SAFETY NOTICE letters were emailed to customers. Actions to be taken by the Customer/User: 1. Confirm receipt of this notice by replying to this email with RECEIVED 2. Please complete the attached Customer Reply Form and email the form to FA2025- 02@defibtech.com. 3. Attached to this Field Safety Notice, you will find the 3 Instructions For Use (Operator Guide) in the required languages. Please take the attached 3 Instructions For Use (Operator Guide) and keep with the affected AED(s). If you have questions now, please feel free to contact us using the email |
| Quantity | 1 unit (OUS only) |
| Distribution | International Only: Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.