Nikon Metrology recalls Nikon Metrology XTH cabinet x-ray Systems which includes variations STH225, XTH225ST, and MCT225.

Recall date

December 23, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1727-2020

FDA classification

Class II

Brand / firm

Nikon Metrology

Sold / distributed

US Nationwide Distribution

Why it was recalled

The manufacturer identified a risk that their products might fail to comply with the cabinet x-ray system performance standard limit on x-ray emissions [21 CFR 1020.40(c)(1)] due to an insufficient safety margin for the means of attachment of a piece of interior x-ray shielding. Double sided industrial tape was used for attachment - there have been only 2 instances of detachment and although the piece of shielding detached it remained mostly in place supported by wires that pass through that piece of shielding. The repair is accomplished by adding a bracket to fasten the piece of shielding securely to the inside of the x-ray system. Mfr reports that no systems were found to have exceeded the emission limit when checked prior to repair.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Nikon Metrology XTH cabinet x-ray Systems which includes variations STH225, XTH225ST, and MCT225.