FDA DeviceClass IINotable

FDA Recall: Fresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH R-100

Date: 2026-06-17
Brand: Fresh Roast Systems Inc
Category: Medical Device
FDA Class: Class II

Description

A defect has been identified in the manufacture of the Fresh Roast Systems ColorTrack instrument model number BENCH R-100 which could under very rare specific misuse circumstances potentially allow human access to infrared laser light levels in excess of the safety Classification of the product.

Hazard

A defect has been identified in the manufacture of the Fresh Roast Systems ColorTrack instrument model number BENCH R-100 which could under very rare specific misuse circumstances potentially allow human access to infrared laser light levels in excess of the safety Classification of the product.

Remedy

38

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