Z-1692-2025 Class II Ongoing
FDA device recall Z-1692-2025 was initiated by Defibtech, LLC on March 18, 2025 and is designated Class II. 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) sh… The recall status is ongoing. Affected quantity: 212 units (OUS only).
Recall Details
- Product Type
- Devices
- Report Date
- May 7, 2025
- Initiation Date
- March 18, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 212 units (OUS only)
Product 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)
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).
Distribution Pattern
International Only: Switzerland.
Code Information
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.