FDA Medical Device Recalls (openFDA)
Defibtech, LLC: Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1(German/English dual language), DCF-E2210-F3/1(French/English dual language)
- Recall number
- Z-1694-2025
- Recalling firm
- Defibtech, LLC
- Product
- Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1(German/English dual language), DCF-E2210-F3/1(French/English dual language)
- Status
- Open, Classified
- Initiated
- 2025-03-18
- Posted
- 2025-04-29
- Terminated
- not on file
- Reason
- 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).
- Root cause
- Process control
- Action
- 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.
- Quantity
- 13 units (OUS only)
- Distribution
- OUS only: Switzerland.
- Lot, serial or model codes
- UDI-DIs; 00815098020195 (DDU-2200, export version), 10815098020192 (DDU-2200, export version (configuration level)); Lot numbers: 400184748, 400170814, 400180780, 400142381, 400142390, 400142995, 400145936, 400145955, 400149039, 400149042, 400149094, 400145977, 400149090,
- 510(k) numbers
- not on file
- PMA numbers
- ["P160032"]
- Product code
- MKJ
- Firm FEI
- 3003521780
- Firm city
- Guilford
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28