Z-1727-2020Class II

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

Name: Z-1727-2020 Nikon Metrology XTH cabinet x-ray Systems which includes variations STH225, XTH225ST, and MCT225
Creator: Nikon Metrology
Published: 2019-12-23
License: https://open.fda.gov/license/

Nikon Metrology / initiated 2019-12-23 / Terminated / root cause: manufacturing process

FDA source

Nikon Metrology began a recall of Nikon Metrology XTH cabinet x-ray Systems which includes variations STH225, XTH225ST, and MCT225 on 2019-12-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1727-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-23
Posted: 2020-05-22
Terminated: 2024-06-13
Recalling firm: Nikon Metrology
Product: Nikon Metrology XTH cabinet x-ray Systems which includes variations STH225, XTH225ST, and MCT225.
Product code: RCE Cabinet X-Ray, Industrial
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.
Root cause tag: manufacturing process
FDA root cause: Radiation Control for Health and Safety Act
Action: 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.
Quantity in commerce: 110 units
Distribution: US Nationwide Distribution
Product codes and lots: all STH225, XTH225ST, and MCT225 units)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1727-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1727-2020	Class II	Terminated	FDA Mandated	2020-06-03	2020-05-22

Product code RCE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)