Recall Z-1692-2025
Defibtech, LLC · initiated March 18, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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)
Codes / lots: UDI-DIs: 00815098020232 (DDU-2300, export version), 10815098020239 (DDU-2300, export version (configuration level)). Lot numbers: 400174411, 400174755, 400175965, 400179100, 400179205, 400179279, 400179223, 400179206, 400179271, 400191481, 400191516, 400197352, 400191375, 400164982, 400155836, 400159075, 400139521, 400168419, 400160156, 400165319, 400190176, 400187549, 400187582, 400190198, 400186761, 400187569, 400150859, 400150811, 400187620, 400150948, 400182206, 400152805, 400200222, 400173689, 400173695, 400170424, 400182464, 400191479, 400179417, 400179733, 400168929, 400179607, 400179275, 400191478, 400151695, 400151696, 400151699, 400151718, 400151724, 400151727, 400151728, 400151730, 400151756, 400151799, 400151802, 400151812, 400151841, 400151843, 400151844, 400151858, 400151905, 400151907, 400151915, 400151920, 400156160, 400186774, 400187567, 400187593, 400187596, 400190090, 400190232, 400190280, 400190303, 400190304, 400190305, 400190318, 400190322, 400190324, 400190355, 400151697, 400151723, 400151851, 400151852, 400151916, 400154576, 400154581, 400154589, 400154595, 400154601, 400154645, 400154646, 400154698, 400154755, 400154839, 400157339, 400157485, 400157486…
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).
FDA-determined cause: Process control
Action taken
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- 02@defibtech.com. 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: FA2025-01@defibtech.com. 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.
Details
- Recall number
- Z-1692-2025
- Initiated
- March 18, 2025
- Posted by FDA
- April 29, 2025
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
- Quantity
- 212 units (OUS only)
- Distribution
- International Only: Switzerland.
- Recalling firm
- Defibtech, LLC, Guilford, CT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1690-2025 Class II | Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers:…It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical… | 03/18/2025Open, Classified |
| Z-1691-2025 Class II | Automated External Defibrillators, Model DDU-2200, IItem numbers:…It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical… | 03/18/2025Open, Classified |
| Z-1693-2025 Class II | Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German…It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical… | 03/18/2025Open, Classified |