Automated External Defibrillators, Model DDU-2200, IItem… recallZ-1694-2025 · Defibtech, LLC · initiated Mar 18, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Defibtech, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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).
FDA root cause category: Process control
What the company is doing
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- [email protected]. 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: [email protected]. 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.
Recall details
- Recall number
- Z-1694-2025
- Status
- Open, Classified
- Initiated by the company
- Mar 18, 2025
- Posted by the FDA
- Apr 29, 2025
- Recalling firm
- Defibtech, LLC
- Quantity
- 13 units (OUS only)
- Product code
- MKJ
- FDA submissions
- P160032
- Distribution
- OUS only: Switzerland.
Product description
Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1(German/English dual language), DCF-E2210-F3/1(French/English dual language)
Code information (models, lots, serial numbers)
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,
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Lifeline VIEW AUTO Configuration DDU-E2200Defibtech, L.L.C. · Automated External Defibrillators (Non-Wearable)2 recalls11 reports
- Lifeline VIEW AUTO DDU-E2200Defibtech, L.L.C. · Automated External Defibrillators (Non-Wearable)2 recalls8 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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