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Ami HTX (Spectral Instruments) – Label Mismatch (2025)

The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not correspond exactly to the labeling stipulated by the FDA / CDRH.

Low

FDAMay 13, 2025Nationwide• Spectral Instruments Inc

MR 5300 (Philips) – Image Alignment Error (2025)

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Low

FDAMay 13, 2025Nationwide• Philips North America Llc

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Ami HTX (Spectral Instruments) – Label Mismatch (2025)

MR 5300 (Philips) – Image Alignment Error (2025)

Kendall SCD Comfort Sleeve (Cardinal Health) – Software Pressure Error (2025)

Allon 2001 Device (Belmont Instrument) – Temperature Wrap Risk (2025)

Lago X (Spectral Instruments) – Label Mismatch (2025)

Ingenia 3.0T CX (Philips) – Image Alignment Error (2025)

SCD Comfort Sleeve (Cardinal Health) – Software Pressure Error (2025)

Evolution Upgrade 1.5T (Philips) – Image Alignment Error (2025)

2025 Dodge Hornet (Dodge) – Rearview Camera Issue (2025)

Ingenia 3.0T (Philips) – Image Alignment Error (2025)

Ingenia 1.5T CX (Philips) – Image Alignment Error (2025)

Kendall SCD Blended Comfort Sleeve (Cardinal Health) – Software Pressure Error (2025)

Ingenia Ambition S (Philips) – Image Alignment Error (2025)

Ingenia Elition X (Philips) – Image Alignment Error (2025)

Ingenia 1.5T (Philips) – Image Alignment Error (2025)

SmartPath 1.5T (Philips) – Image Alignment Error (2025)

Vallarai Rice Mix (NatureMills) – Undeclared Wheat (2025)

Dal Garlic Rice Mix (NatureMills) – Milk and Wheat (2025)

Sesame Rice Mix (NatureMills) – Undeclared Milk (2025)

Traditional Sambar Powder (NatureMills) – Multiple Allergens (2025)