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RecallWatchMedical Device Safety
Class IIOngoingZ-1692-2025

Defibtech, LLC recalls Automated External Defibrillators

Defibtech, LLCGuilford, CT, United StatesReported May 7, 2025 · 1 year ago
Legal News Analyst ·

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).

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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)UDI
    212 affected lots
    400174411400174755400175965400179100400179205400179279400179223400179206
    +204 more400179271400191481400191516400197352400191375400164982400155836400159075400139521400168419400160156400165319400190176400187549400187582400190198400186761400187569400150859400150811400187620400150948400182206400152805400200222400173689400173695400170424400182464400191479400179417400179733400168929400179607400179275400191478400151695400151696400151699400151718400151724400151727400151728400151730400151756400151799400151802400151812400151841400151843400151844400151858400151905400151907400151915400151920400156160400186774400187567400187593400187596400190090400190232400190280400190303400190304400190305400190318400190322400190324400190355400151697400151723400151851400151852400151916400154576400154581400154589400154595400154601400154645400154646400154698400154755400154839400157339400157485400157486400157489400157490400157510400157512400157514400157516400157521400150824400150860400150932400141200400141209400141210400141239400141257400141260400141266400141275400148165400148173400148186400148208400148213400148247400148275400150548400150839400150846400150847400150848400150873400150888400150894400150899400150903400150912400150915400150916400150921400150930400150933400150936400150937400150958400150959400150962400150965400150968400150969400150979400150991400156277400156418400156430400156431400187368400187561400187579400187601400190175400150825400150892400150911400150964400187539400187583400190295400187697400187703400187704400187708400187719400187730400187747400190293400190365400190366400190381400190412400190415400081869400081970400170423400173514400154604400154608400154609400154613400154666400154671400154684400154798400154799400154810400168739400168745400168809400168926400168943400168951400168997400172421400173420400173433400173489400173496400173509400173513400173539400173540400159593400159613400162216400162221400162248

What the firm is doing

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.

DistributionShow details

International Only: Switzerland.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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