PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: June 3, 2020 Initiated: December 23, 2019 #Z-1727-2020

Product Description

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

Reason for Recall

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.

Details

Recalling Firm
Nikon Metrology
Units Affected
110 units
Distribution
US Nationwide Distribution
Location
Brighton, MI

Frequently Asked Questions

What product was recalled?
Nikon Metrology XTH cabinet x-ray Systems which includes variations STH225, XTH225ST, and MCT225.. Recalled by Nikon Metrology. Units affected: 110 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 3, 2020. Severity: Moderate. Recall number: Z-1727-2020.