Nikon Metrology: Medical Device Recall in 2020 - (Recall #: Z-1727-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 23, 2019

Date Posted: June 3, 2020

Recall Number: Z-1727-2020

Event ID: 85498

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.

Status: Terminated

Product Quantity: 110 units

Code Information:

all STH225, XTH225ST, and MCT225 units)

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

FDA Mandated