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Recall Observatory FDA recall evidence

Device product

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.

Z-1007-2017

December 12, 2016

Class II

Product summary

Firm
Medtronic Navigation, Inc.
Event
Event 76060
Status
Terminated
Classification
Class II
Quantity
111 devices
Official record key
device-enforcement:Z-1007-2017

Official wording

Reason: 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.

Code information: lot number 150626B

Distribution pattern: US Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.