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U.S. Department of Health and Human Services

Class 2 Device Recall Nikon Metrology XTH Systems (all STH225, XTH225ST, and MCT225 units) Cabinet Xray Systems

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 Class 2 Device Recall Nikon Metrology XTH Systems (all STH225, XTH225ST, and MCT225 units) Cabinet Xray Systemssee related information
Date Initiated by FirmDecember 23, 2019
Create DateMay 22, 2020
Recall Status1 Terminated 3 on June 13, 2024
Recall NumberZ-1727-2020
Recall Event ID 85498
Product Classification Cabinet x-ray, industrial - Product Code RCE
ProductNikon Metrology XTH cabinet x-ray Systems which includes variations STH225, XTH225ST, and MCT225.
Code Information all STH225, XTH225ST, and MCT225 units)
Recalling Firm/
Manufacturer		 Nikon Metrology
12701 Grand River Rd
Brighton MI 48116
For Additional Information ContactJeff Root
810-220-4360
Manufacturer 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.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionNikon 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 Commerce110 units
DistributionUS Nationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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