Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language)
Reported: May 7, 2025 Initiated: March 18, 2025 #Z-1693-2025
Product Description
Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language)
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).
Details
- Recalling Firm
- Defibtech, LLC
- Units Affected
- 1 unit (OUS only)
- Distribution
- International Only: Switzerland.
- Location
- Guilford, CT
Frequently Asked Questions
What product was recalled? ▼
Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language). Recalled by Defibtech, LLC. Units affected: 1 unit (OUS only).
Why was this product 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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 7, 2025. Severity: Moderate. Recall number: Z-1693-2025.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11