Nikon Metrology XTH Cabinet X-Ray Systems Recalled for Shielding Defect
Nikon Metrology is recalling 110 XTH cabinet x-ray systems because interior shielding may detach, potentially causing x-ray emissions to exceed safety limits.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of x-ray emission limit exceedance, a significant health hazard, but no injuries or illnesses have been reported, fitting the High severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Nikon Metrology is recalling 110 units of XTH cabinet x-ray systems, including variations STH225, XTH225ST, and MCT225, distributed nationwide in the United States. The recall was initiated because the manufacturer identified a risk that the products might fail to comply with the cabinet x-ray system performance standard limit on x-ray emissions. This non-compliance could occur due to an insufficient safety margin for the attachment of a piece of interior x-ray shielding, which was secured using double-sided industrial tape.
The manufacturer reports that there have been only two instances of the shielding detaching, though in those cases the shielding remained mostly in place due to wires passing through it. No systems were found to have exceeded the emission limit when checked prior to repair. The repair involves adding a bracket to fasten the piece of shielding securely to the inside of the x-ray system.
The recalled product
- Product
- Nikon Metrology XTH cabinet x-ray Systems which includes variations STH225, XTH225ST, and MCT225.
- Manufacturer
- Nikon Metrology
- Affected units
- 110
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- all STH225
- XTH225ST
- and MCT225 units)
Distribution
Distributed nationwide across the United States.
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