Spectral Instruments Recalls 35 Ami HTX X-Ray Units
Spectral Instruments Inc is recalling 35 Ami HTX units because the 'X-Ray On' banner may briefly disappear during the run readiness check.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a momentary display issue during a readiness check without reported injuries, fitting the criteria for a moderate severity recall.
Plain-English summary
Spectral Instruments Inc is recalling 35 units of the Ami HTX product. The recall is due to a momentary absence of the On-Screen "X-Ray On" banner during the run readiness check.
The affected units are distributed in the United States. The recall covers all serial numbers for this specific product quantity.
Consumers and healthcare providers should contact Spectral Instruments Inc for further instructions on how to address this issue.
The recalled product
- Product
- Ami HTX
- Manufacturer
- Spectral Instruments Inc
- Hazard
- Affected units
- 35
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)
- All serial numbers.
Distribution
Distribution scope not specified by the agency.
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