FDA Device recall Z-1727-2020
Nikon Metrology XTH cabinet x-ray Systems which includes variations STH225, XTH225ST, and MCT225
- FDA Device
- Class II
- terminated
- Published 2020-06-03
On 2020-06-03 the FDA classified a Class II recall of Nikon Metrology XTH cabinet x-ray Systems which includes variations STH225, XTH225ST, and MCT225 by Nikon Metrology, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1727-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-23 |
| Published | 2020-06-03 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Nikon Metrology |
| Distribution | US |
Product
Nikon Metrology XTH cabinet x-ray Systems which includes variations STH225, XTH225ST, and MCT225.
Reason
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.
Identifiers
| code_info | all STH225, XTH225ST, and MCT225 units) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1727-2020%22
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