The sphere manufacturer has identified a variation in the reflective material used on a limited number of sterile passive sphere lots. The reflective material is the outer coating of the sphere that reflects infrared light from the optical tracking cameras, enabling detection and tracking of instruments during navigation procedures.
Potential impacts may include instrument verification failures, intermittent or lost tracking, red status tracking, or reduced navigation accuracy.
規制動向2026年9月16日•3分で読めます
Medtronic Identifies Reflective Material Variation in Sterile Passive Spheres
Health Canada reports a limited number of Medtronic sterile passive spheres have variable reflective coating that could affect navigation system tracking.
Pharmacountryチームがまとめました · 出典： Health Canada
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