Recall Z-1727-2020— Nikon Metrology
Class II · Terminated
Class II FDA medical device recall by Nikon Metrology, initiated 2019-12-23, terminated 2024-06-13. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Nikon Metrology
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-12-23
- Terminated
- 2024-06-13
- Firm location
- Brighton, MI, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.