Semi-automated external defibrillators lack required Italian language instructions
Defibtech semi-automated external defibrillators distributed to Switzerland lack required Italian translations of product information and instructions for use, violating Swiss Medical Devices Ordinance requirements for multilingual labeling.
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 documentation and labeling issue with no reported illnesses, injuries, or actual product defects. The hazard is purely regulatory and compliance-based. Per the FDA severity rubric, documentation issues without reported incidents are classified as Score 1.
Plain-English summary
Defibtech, LLC is recalling semi-automated external defibrillators (AED), models DDU-100 and DDU-100E, due to missing Italian language translations of product information and instructions for use.
Swiss Medical Devices Ordinance (MedDO) Article 16 requires that product information, including labeling and instructions for use, be provided in all three official languages of Switzerland: German, French, and Italian. The recalled devices lack the required Italian translation.
The recall affects 43 units distributed exclusively to Switzerland. Consumers who received these devices should contact Defibtech, LLC for corrected product information in Italian or for device replacement.
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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