Nikon Metrology XTH cabinet x-ray Systems which includes variations… — Class II medical device recall Z-1727-2020
Terminated recall by Nikon Metrology, reported 2020-06-03, distributed nationwide. The manufacturer identified a risk that their products might fail to comply with the cabinet x-ray system perf
| Recall number | Z-1727-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Nikon Metrology, Brighton, MI, United States |
| Recall initiated | 2019-12-23 |
| Classified | 2020-05-22 |
| Reported by FDA | 2020-06-03 |
| Terminated | 2024-06-13 |
| Distributed | Nationwide (US) |
| Quantity | 110 units |
| Reason classes | device malfunction |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1727-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.