FDA-Device2017-01-18Class II
AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed with a Tyvek lid and then placed in a shelf carton.
Medtronic Navigation, Inc.
Hazard
Medtronic Navigation, Inc. announces a voluntary field action for the AxIEM Touch N Go Pointer Probe because the patient registration accuracy may compromise navigation accuracy when using the StealthStation¿ System with Touch N Go Pointer Probes for patient registration.
Sold states
US Nationwide Distribution.
Affected count
111 devices
Manufactured in
826 Coal Creek Cir, Louisville, CO, United States
Products
AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed with a Tyvek lid and then placed in a shelf carton.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1007-2017Don't want to check this manually?
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