Reported Jun 3, 2020 · Terminated

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

Nikon Metrology

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Nikon Metrology · 12701 Grand River Rd · Brighton, MI · 48116

Is this the product you have?

  • Nikon Metrology XTH cabinet x-ray Systems which includes variations STH225, XTH225ST, and MCT225.
Lot codes and dates
    • all STH225
    • XTH225ST
    • and MCT225 units)
Amount recalled
110 units

Where it was sold

  • Nationwide

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 13, 2024 · Data as of Sep 19, 5:34 PM UTC

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