Recall Z-1694-2025 ยท MKJ Automated External Defibrillators (Non-Wearable)
Defibtech, LLC
Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1(German/English dual language), DCF-E2210-F3/1(French/English dual 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 sent to customers. Actions to be taken by the Customer/User: 1. Confirm receipt of this notice by replying to this email with RECEIVED 2. Locate and verify the SN affected by this Field Notice listed below. The serial number is located at the back of the Lifeline View Fully Automatic Defibrillator. 3. Please complete the attached Customer Reply Form and email the form to FA2025- 01@defibtech.com. 4. Once the Customer Reply Form is received, Defibtech will contact you to arrange disposition based on your selection. Your device wil |
| Quantity | 13 units (OUS only) |
| Distribution | OUS only: Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.