January 18, 2022
FDA: Class I recall of Medtronic Synergy Cranial, StealthStation S7 cranial software
Editor's Note
The Food and Drug Administration (FDA) on January 6 identified the recall by Medtronic of its Stealth Station System with Synergy Cranial and StealthStation S7 Cranial Software as Class I, the most serious.
The System aids in precisely locating anatomical structures in neurosurgical procedures.
The recall was initiated because of potential inaccuracies caused by the Biopsy Depth Gauge Cycle View.
There have been four complaints, and no reported injuries or deaths.
Distribution dates were May 1, 2019 to October 29, 2021.
Free Daily News
- Survey assesses continued impact of Change Healthcare cyberattack
- WHO sounds alarm on potential spread of bird flu
- Allison Massari to deliver hopeful, empowering keynote address at OR Manager Conference 2024
- Neurosurgery trial: Early evacuation improves long-term hemorrhage outcomes
- Drug shortages higher than ever
- FDA announces class 1 recalls for premixed embolic, infusion pump software
- Academic medical centers identify performance-improvement priorities
- Propofol anesthesia for colonoscopy could help find polyps, prevent cancer
- FDA Class 1 recall renews concern about historically problematic heart pumps
- New physician compensation report reveals modest pay gains but growing discontent with the profession
© Access Intelligence, LLC. All rights reserved. | Privacy Policy | Diversity, Equity, Inclusion & Belonging