Defibtech Automated External Defibrillators Model DDU-2200 Missing Italian Translation
Defibtech is recalling Automated External Defibrillators Model DDU-2200 distributed in Switzerland due to missing Italian translation of product labeling and instructions, which violates Swiss Medical Devices Ordinance requirements.
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/labeling deficiency with no reported safety hazard or risk of adverse health consequences. The issue involves missing translation rather than a functional device defect, placing it within the Low severity category for labeling and documentation issues.
Plain-English summary
Defibtech, LLC is recalling Automated External Defibrillators, Model DDU-2200 (Item numbers DCF-E2210-D3/1 for German/English dual language and DCF-E2210-F3/1 for French/English dual language). The recall affects 13 units distributed outside the United States in Switzerland only.
The recall was initiated because the product documentation lacks an Italian translation. According to Article 16 of the Swiss Medical Devices Ordinance (MedDO), product information including labeling and instructions for use must be provided in all three official languages of Switzerland: German, French, and Italian.
The affected lot numbers are: 400184748, 400170814, 400180780, 400142381, 400142390, 400142995, 400145936, 400145955, 400149039, 400149042, 400149094, 400145977, and 400149090. Consumers in Switzerland who have received this device should contact Defibtech, LLC regarding the missing Italian translation documentation.
The recalled product
- Product
- Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual language)
- Manufacturer
- Defibtech, LLC
- Hazard
- labeling-non-compliance
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 (18)
- UDI-DIs
- 00815098020195 (DDU-2200
- export version)
- 10815098020192 (DDU-2200
- export version (configuration level))
- Lot numbers: 400184748
- 400170814
- 400180780
- 400142381
- 400142390
- 400142995
- 400145936
- 400145955
- 400149039
- 400149042
- 400149094
- 400145977
- 400149090
Distribution
Distribution scope not specified by the agency.
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