Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E22
Summary
The FDA issued a Class II for Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1 by Defibtech, LLC. 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 i.
Details
Source
Device Recall
External ID
Z-1691-2025
Action Date
2025-05-07
Status
Ongoing
Category
device
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)
Lot/Code Info: 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,
Quantity Affected: 13 units (OUS only)
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).
Distribution
International Only: Switzerland.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-03-18
Company
Guilford, CT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 149 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Defibtech, LLC has 12 FDA actions in our database, including 11 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Defibtech, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Defibtech, LLC have FDA actions?
Defibtech, LLC has 12 FDA actions in our database, including 11 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1691-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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