CanadaNDI Passive Spheres™ (model/catalogue numbers 8801071, 8801074 and 8801075; lots/serial numbers with more than 10 digits—contact Northern Digital Inc.) are affected. The manufacturer identified variation in the spheres’ reflective outer coating that may affect the navigation system’s ability to detect and track the spheres, potentially causing instrument verification failures, intermittent or lost tracking, red status tracking or navigation accuracy. Contact the manufacturer if you require additional information.
What's being recalled
Companies: Northern Digital Inc., 103 Randall Drive, Waterloo, Ontario, Canada, N2V 1C5.
How to identify it
Affected products: NDI Passive Spheres™; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 8801071
Affected products: NDI Passive Spheres™; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 8801074
Affected products: NDI Passive Spheres™; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 8801075
The hazard
The sphere manufacturer has identified 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. Medtronic has determined that this variability may affect the ability of the navigation system to detect and track the spheres. Potential impacts may include instrument verification failures, intermittent or lost tracking, red status tracking or navigation accuracy.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)