FDA-Device2015-07-22Class II
NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery) system. Product Usage: Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in the surgical field.
Northern Digital Inc.
Hazard
Inadequate curing of adhesive, which may cause the two halves of the spheres to separate.
Sold states
Worldwide - US Nationwide Distribution and the countries of Australia and Canada.
Affected count
32,400 spheres
Manufactured in
103 Randall Drive, N/A, Waterloo, Ontario, Canada
Products
NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery) system. Product Usage: Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in the surgical field.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2093-2015Don't want to check this manually?
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