Automated External Defibrillators, Model DDU-2300. Item numbers: DCF-E2310D3/1(German/English dual language), DCF-E2310E

FDA device recall Z-1692-2025 · posted 2025-04-29 · Open, Classified

Recall details

Recalling firm

Defibtech, LLC

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).

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.

Root cause

Process control

Status

Open, Classified

Product code

MKJ

Quantity affected

212 units (OUS only)

Distribution

International Only: Switzerland.

Date initiated

2025-03-18

Date posted

2025-04-29

Location

Guilford, CT