Fresh Roast ColorTrack instruments may allow excess infrared laser exposure
Fresh Roast Systems ColorTrack instruments, model BENCH R-100, are being recalled because a manufacturing defect could allow access to infrared laser light above the product's safety classification.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with a stated risk of laser exposure above the product's safety classification, a risk of harm with no injuries reported.
Plain-English summary
The Fresh Roast Systems ColorTrack instrument, model number BENCH R-100, is being recalled. The action covers 38 units.
A defect has been identified in the manufacture of the instrument which, according to the manufacturer, 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. The FDA classified the action as Class II.
Distribution was within the United States. The recall notice provides only the model number for identification.
Users should identify affected instruments by the model number above and follow the instructions issued by Fresh Roast Systems.
The recalled product
- Product
- Fresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH R-100
- Manufacturer
- Fresh Roast Systems Inc
- Affected units
- 38
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Only Model Number provide. Model Number: BENCH R-100
Distribution
Distribution scope not specified by the agency.
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