Spectral Instruments recalls Lago X/AMI HTX instruments due to X-ray safety and manufacturing date labels not matching FDA requirements. Affected units may have incorrect labeling.
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 Lago X/AMI HTX medical imaging devices because their X-ray safety and manufacturing date labels don't match FDA regulations. This mismatch could lead to incorrect labeling of the device's safety features.
The X-ray safety and manufacturing date labels on the device do not match the FDA's required labeling. This mismatch could result in incorrect identification of the device's safety features, potentially affecting proper use.
Medical professionals using the Lago X/AMI HTX devices are likely affected. Patients and staff at facilities using these devices may be at risk if the labeling error impacts device safety.
Check for the Lago X/AMI HTX device with an accession number of 2510787-000. The device may have incorrect X-ray safety or manufacturing date labels as per FDA regulations.
Verify the X-ray safety and manufacturing date labels on the device to ensure they match FDA requirements.
The X-ray safety and manufacturing date labels on the Lago X/AMI HTX device do not match the FDA's required labeling, which could affect device safety.
Check the device labels to ensure they match FDA requirements. If labels are incorrect, contact Spectral Instruments for further instructions.
The recall record does not specify a remedy or fix for the labeling issue.
We’ve drafted a message you can send Spectral Instruments to request your refund or repair — edit it as you like.
Subject: Recall Z-1941-2025 — Spectral Instruments Spectral Instruments Hello, I own a Spectral Instruments that is covered by recall Z-1941-2025 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.
