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.
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: 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
- Affected units
- 34
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.
Part of a larger recall action
This product is one of 2 recalled by Spectral Instruments Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Spectral Instruments Inc
See all →- ModerateSpectral Instruments Lago X Medical Device Recalled for Display Glitch
FDA (Devices) · 2026-08-26
- ModerateSpectral Instruments Recalls 35 Ami HTX X-Ray Units
FDA (Devices) · 2026-08-26
- ModerateLago X X-ray instrument recall due to labeling discrepancies
FDA (Devices) · 2025-06-25
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- LowMagellan LeadCare II Blood Lead Test Kit Recall for Labeling Error
FDA (Devices) · 2026-10-21
- ModerateIn2bones Recalls Partially Threaded Bone Screws Due to Labeling Error
FDA (Devices) · 2026-10-21
- SevereInstrumentation Laboratory Recalls HemoslL AcuStar HIT-lgG In Vitro Diagnostic Reagents
FDA (Devices) · 2026-10-21
- SevereDeano's Pasta Recalls Pear and Pecorino Ravioli for Undeclared Lobster
FDA (Food) · 2026-10-21
Similar recalls
- ModerateSpectral Instruments Recalls 35 Ami HTX X-Ray Units
FDA (Devices) · 2026-08-26
- LowPhilips IQon Spectral CT System Recalled for Incorrect Label Rating
FDA (Devices) · 2016-11-23
- ModerateAd-Tech Skull Anchor Bolts Recalled for Incorrect MRI Approval Labeling
FDA (Devices) · 2019-09-04
- ModerateMedtronic O-arm Imaging System Recalled for Labeling Compliance Gaps
FDA (Devices) · 2014-03-12
- HighFDA Recalls Axium Detachable Coil Systems for Incorrect Labeling
FDA (Devices) · 2022-06-22
- ModerateMedtronic Navigation O-arm 02 surgical x-ray system recalled for labeling gaps
FDA (Devices) · 2016-07-13