Spectral Instruments recalls Ami HTX X-ray instruments due to mismatched FDA-compliant safety labels. Affected units may not meet regulatory standards for radiation safety.
The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not correspond exactly to the labeling stipulated by the FDA / CDRH.
Spectral Instruments is recalling its Ami HT: X-ray instruments because the safety and manufacturing date labels on the devices don't match FDA requirements. This mismatch could lead to improper radiation safety labeling, potentially affecting patient or operator safety.
The X-ray safety and manufacturing date labels on the Ami HTX instruments do not match the FDA's required labeling. This mismatch could result in incorrect radiation safety information being displayed, which might lead to improper use or safety risks.
Users of the Ami HTX X-ray instruments who purchased them from Spectral Instruments or authorized dealers. Medical professionals and patients using these devices are at risk if the labels don't meet FDA standards.
Check for the Ami HTX X-ray instrument with a label that shows the safety and manufacturing date. The product was sold by Spectral Instruments or authorized dealers.
Verify the X-ray safety and manufacturing date labels on the Ami HTX instrument to ensure they match FDA requirements.
The X-ray safety and manufacturing date labels on the Ami HTX instruments do not match the FDA's required labeling standards.
Check if the X-ray safety and manufacturing date labels on your Ami HTX instrument match FDA requirements.
The recall does not specify a remedy, so contact Spectral Instruments for further guidance.
We’ve drafted a message you can send Spectral Instruments to request your refund or repair — edit it as you like.
Subject: Recall Z-1942-2025 — Spectral Instruments Spectral Instruments Hello, I own a Spectral Instruments that is covered by recall Z-1942-2025 from Spectral Instruments. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
