Device evidence

device-recall:cfres:207180

Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures.

Official recall number

Z-1776-2024

Evidence summary

Product code: HAW
Recall status: Open, Classified
Event initiated: March 26, 2024
Root cause: Software design
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-1776-2024