Semi-Automated External Defibrillators Missing Italian Language Labeling
Defibtech is recalling semi-automated external defibrillators (Models DDU-100 and DDU-100E) distributed in Switzerland because they lack required Italian language labeling and instructions for use.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is a labeling deficiency—specifically, missing translation into one of three required official languages—with no reported injuries or safety hazards. The issue is regulatory non-compliance regarding product documentation, not a device malfunction or health risk, consistent with FDA Class II cosmetic or documentation-level defects.
Plain-English summary
Defibtech, LLC is recalling semi-automated external defibrillators (AEDs), Models DDU-100 and DDU-100E, distributed internationally in Switzerland. The recalled units include item numbers DCF-E110SG-DE/1 (German), DCF-E110SG-FR/1 (French), and DCF-E110SG-IT/1 (Italian). A total of 43 units have been distributed.
The defibrillators were found to lack Italian language translation for product information, labeling, and instructions for use. Article 16 of the Swiss Medical Devices Ordinance (MedDO) requires that product information be provided in all three official languages of Switzerland: German, French, and Italian.
Defibtech has identified the affected lot numbers, which include 114008193, 114007350, 114007323, 114008190, 116012370, 116011831, and 36 additional lot numbers. If you have received one of these devices, contact Defibtech, LLC immediately.
The recalled product
- 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)
- Manufacturer
- Defibtech, LLC
- Hazard
- mis-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distribution scope not specified by the agency.
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