FDA Device recall Z-1690-2025
Semi-Automated External Defibrillators
- FDA Device
- Class II
- ongoing
- Published 2025-05-07
On 2025-05-07 the FDA classified a Class II recall of Semi-Automated External Defibrillators by Defibtech, citing 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 inst….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1690-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-18 |
| Published | 2025-05-07 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Defibtech |
| Distribution | n/a |
Product
Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), DCF-E110SG-FR/1 (French language), DCF-E110SG-IT/1 (Italian language)
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).
Identifiers
| code_info | UDI-DIs: 00815098020034 (DDU-100, export version), 10815098020031 (DDU-100, export version (configuration level)). Lot…UDI-DIs: 00815098020034 (DDU-100, export version), 10815098020031 (DDU-100, export version (configuration level)). Lot numbers: 114008193, 114007350, 114007323, 114008190, 116012370, 116011831, 114006014, 114006766, 114006943, 114007067, 114007068, 114007071, 114007078, 114007091, 114007114, 114007123, 114007128, 114007137, 114007145, 114007478, 114007486, 114007517, 114007623, 114007696, 114007705, 114007770, 114007906, 114007907, 114007911, 114007914, 114007925, 114007933, 114007934, 114007964, 116011703, 116011708, 116011883, 116012476, 116012485, 116012488, 116012501, 104016266, 104016297, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1690-2025%22
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