# FDA recall Z-1727-2020

> **Nikon Metrology** · Class II · device recall initiated 2019-12-23.

## Product

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.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-1727-2020
- **Recalling firm:** Nikon Metrology
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-12-23
- **Report date:** 2020-06-03
- **Termination date:** 2024-06-13

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Brighton, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1727-2020

## Citation

> AI Analytics. FDA recall Z-1727-2020. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1727-2020. Source: US FDA. Licensed CC0.

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