Nikon Metrology Nikon Metrology XTH cabinet x-ray Systems which includes variations STH225, XTH225ST, and MCT225. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Nikon Metrology XTH cabinet x-ray Systems which includes variations STH225, XTH225ST, and MCT225.
Brand
Nikon Metrology
Lot Codes / Batch Numbers
all STH225, XTH225ST, and MCT225 units)
Products Sold
all STH225, XTH225ST, and MCT225 units)
Nikon Metrology is recalling Nikon Metrology XTH cabinet x-ray Systems which includes variations STH225, XTH225ST, and MCT225. due to The manufacturer identified a risk that their products might fail to comply with the cabinet x-ray system performance standard limit on x-ray emission. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Nikon sent Notification letters to affected customers. The letter identified the Description of the Possible Defect, Potential Health Risk from the Defect, and actions to be taken. For question contact the service department via email at xray-support.nm-us@nikon or phone at (810)220-4360.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026