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External Defibrillators DDU-100 (Defibtech) – translation missing (2025)

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).

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FDAMar 18, 2025Nationwide• Defibtech, LLC

External Defibrillators DDU-2200 (Defibtech) – translation missing (2025)

Low

FDAMar 18, 2025Nationwide• Defibtech, LLC

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External Defibrillators DDU-100 (Defibtech) – translation missing (2025)

External Defibrillators DDU-2200 (Defibtech) – translation missing (2025)

META-TAN Screw Kit (Smith & Nephew) – compression screw issue (2025)

DxC 500 AU Analyzer (Beckman Coulter) – result processing error (2025)

Amplatzer TorqVue LP Delivery System (Abbott) – shaft breach (2025)

Amplatzer TorqVue LP Catheter (Abbott) – shaft breach (2025)

Dried Cranberries (Victor Packing) – Mislabeled Carbohydrates (2025)

Gold Garlic Powder (Pacific Meridian) – Metal Contamination (2025)

Atorvastatin Tablets (Biocon) – Dissolution Failure (2025)

EsophyX Z+ (Merit Medical) – device rotation risk (2025)

EsophyX Z+ (Merit Medical) – device rotation risk (2025)

DORO Easy-Connect Navigator (Pro-Med) – reference array issue (2025)

Celsior Storage Solution (Institut Georges Lopez) – contamination risk (2025)

Saxagliptin Tablets (Glenmark) – CGMP Deviations (2025)

HeartMate Mobile Power Unit (Thoratec) – electrical component failure (2025)

Diltiazem Extended-Release Capsules (Glenmark) – CGMP Deviations (2025)

Levetiracetam Injection (Dr. Reddy's) – Labeling Error (2025)

Propafenone Extended-Release Capsules (Glenmark) – CGMP Deviations (2025)

Pravastatin Sodium Tablets (Glenmark) – CGMP Deviations (2025)

Fluphenazine Tablets (Glenmark) – CGMP Deviations (2025)