Automated External Defibrillators DDU-2200 Missing Italian Language Translation
Defibtech is recalling Automated External Defibrillators Model DDU-2200 distributed in Switzerland because they lack required Italian language labeling and instructions for use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class II recall involving a labeling/documentation issue—missing Italian translation—with no report of device malfunction, injury, or adverse health consequences. The hazard is regulatory non-compliance rather than a risk of harm to the device's intended function.
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 affected devices were distributed internationally to Switzerland only. A total of 13 units have been recalled.
The recall was initiated because the product labeling and instructions for use were not provided in all three official languages of Switzerland. Article 16 of the Swiss Medical Devices Ordinance (MedDO) requires product information to be provided in German, French, and Italian. The recalled devices lack the required Italian translation.
The affected units are identified by the following lot numbers: 400184748, 400170814, 400180780, 400142381, 400142390, 400142995, 400145936, 400145955, 400149039, 400149042, 400149094, 400145977, and 400149090.
If you have one of these devices, contact Defibtech, LLC for further instructions regarding the recall.
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
- Affected units
- 13
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.
Part of a larger recall action
This product is one of 4 recalled by Defibtech, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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