Howmedica Osteonics Corp.: Neurological Stereotaxic Instrument

When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an inability to use the device.

Tags

FDA recall, medical device, class 2, Neurology, Under Investigation by firm, Open, Classified

Related exam domains

CISSP 3: Security Architecture and Engineering; CISSP 8: Software Development Security

Source record id

Z-0963-2026

First seen by InfoSec Signals

9/23/2026

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