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)
Enforcement
- Recall Number
- Z-1692-2025
- Event ID
- 96618
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Defibtech, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- May 7, 2025
- Initiation Date
- March 18, 2025
- Classification Date
- April 29, 2025
- Address
- 741 Boston Post Rd Ste 201, Guilford, CT, 06437-2714, United States
Description
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)
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).
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, 400157489, 400157490, 400157510, 400157512, 400157514, 400157516, 400157521, 400150824, 400150860, 400150932, 400141200, 400141209, 400141210, 400141239, 400141257, 400141260, 400141266, 400141275, 400148165, 400148173, 400148186, 400148208, 400148213, 400148247, 400148275, 400150548, 400150839, 400150846, 400150847, 400150848, 400150873, 400150888, 400150894, 400150899, 400150903, 400150912, 400150915, 400150916, 400150921, 400150930, 400150933, 400150936, 400150937, 400150958, 400150959, 400150962, 400150965, 400150968, 400150969, 400150979, 400150991, 400156277, 400156418, 400156430, 400156431, 400187368, 400187561, 400187579, 400187601, 400190175, 400150825, 400150892, 400150911, 400150964, 400187539, 400187583, 400190295, 400187697, 400187703, 400187704, 400187708, 400187719, 400187730, 400187747, 400190293, 400190365, 400190366, 400190381, 400190412, 400190415, 400081869, 400081970, 400170423, 400173514, 400154604, 400154608, 400154609, 400154613, 400154666, 400154671, 400154684, 400154798, 400154799, 400154810, 400168739, 400168745, 400168809, 400168926, 400168943, 400168951, 400168997, 400172421, 400173420, 400173433, 400173489, 400173496, 400173509, 400173513, 400173539, 400173540, 400159593, 400159613, 400162216, 400162221, 400162248.
International Only: Switzerland.
212 units (OUS only)