Recall Z-1727-2020 ยท RCE Cabinet X-Ray, Industrial
Nikon Metrology
Nikon Metrology XTH cabinet x-ray Systems which includes variations STH225, XTH225ST, and MCT225.
| Date | Dec 23, 2019 |
| Status | Terminated |
| 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 se |
| 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 | 110 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.