Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1(German/English dual language), DCF-E221

FDA device recall Z-1694-2025 · 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 sent to customers. Actions to be taken by the Customer/User: 1. Confirm receipt of this notice by replying to this email with RECEIVED 2. Locate and verify the SN affected by this Field Notice listed below. The serial number is located at the back of the Lifeline View Fully Automatic Defibrillator. 3. Please complete the attached Customer Reply Form and email the form to FA2025- 01@defibtech.com. 4. Once the Customer Reply Form is received, Defibtech will contact you to arrange disposition based on your selection. Your device will be refunded or replaced at no cost to you. 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 Standard Time), Monday - Friday. Thank you for your attention and cooperation.

Root cause

Process control

Status

Open, Classified

Product code

MKJ

Quantity affected

13 units (OUS only)

Distribution

OUS only: Switzerland.

Date initiated

2025-03-18

Date posted

2025-04-29

Location

Guilford, CT