Summary
The FDA issued a Class II for Ami HTX. by Spectral Instruments Inc. Reason: 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 F.
Details
Source
Device Recall
External ID
Z-1942-2025
Action Date
2025-06-25
Status
Ongoing
Category
device
Product Description
Ami HTX.
Lot/Code Info: Accession number 2510780-000
Quantity Affected: 34
Reason for Recall
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.
Distribution
US
Type: FDA Mandated
Recall Initiated: 2025-05-13
Company
Tucson, AZ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 167 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Spectral Instruments Inc has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Spectral Instruments Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Spectral Instruments Inc have FDA actions?
Spectral Instruments Inc has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1942-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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