Ami HTX X-ray Instrument Safety Labels Do Not Match FDA Requirements
Spectral Instruments Inc is recalling the Ami HTX X-ray instrument because the safety and manufacturing date labels do not match FDA requirements.
What this means for you
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: This is an FDA Class II recall involving labeling non-compliance with no reported injuries or illnesses. The hazard is regulatory/compliance-based rather than an immediate safety threat, placing it in the Moderate category.
Plain-English summary
Spectral Instruments Inc is recalling the Ami HTX X-ray instrument due to labeling discrepancies. The X-ray safety and manufacturing date labels affixed to the instrument do not correspond exactly to the labeling stipulated by the FDA/CDRH.
Affected units include 34 Ami HTX instruments distributed in the US with accession number 2510780-000. Customers who have received this device should contact Spectral Instruments Inc for corrected labeling or further instructions.
The recalled product
- Product
- Ami HTX.
- Manufacturer
- Spectral Instruments Inc
- Category
- Medical Device — X-ray Equipment
- Hazard
- mis-labeling
- regulatory-noncompliance
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)
- Accession number 2510780-000
Distribution
Distribution scope not specified by the agency.
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