Automated External Defibrillators, Model DDU-2300. Item numbers: DCF-E2310D3/1(German/English dual language), DCF-E2310E3/1(German/French dual language), DCF-E2310F3/1 (French/English dual language), DCF-E2310G3/1(French/German dual language), DCF-E2310IT (Italian language)
FDA Recall Z-1692-2025 · Posted 2025-04-29
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Recalling FirmDefibtech, LLC
Recall StatusOpen, Classified
Product CodeMKJ
Date Initiated2025-03-18
Product Quantity212 units (OUS only)
Reason for Recall
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).
Firm Action
On March 18, 2025 URGENT FIELD SAFETY NOTICE letters were emailed to customers. Actions to be taken by the Customer/User:
1. Confirm receipt of this notice by replying to this email with RECEIVED
2. Please complete the attached Customer Reply Form and email the form to FA2025-
[email protected].
3. Attached to this Field Safety Notice, you will find the 3 Instructions For Use (Operator Guide) in
the required languages. Please take the attached 3 Instructions For Use (Operator Guide) and
keep with the affected AED(s).
If you have questions now, please feel free to contact us using the email address:
[email protected].
Defibtech is committed to ensuring our products meet the highest quality standards and that our
customers are fully supported. I sincerely apologize for any inconvenience this may cause you. As
always, Defibtech Customer Support is available by calling 1-877-453-4507, 7:30 A.M. to 6:00 P.M.
(Eastern), Monday - Friday.
Thank you for your attention and cooperation.
Root Cause
Process control
Distribution Pattern
International Only: Switzerland.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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