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
- Simulation-based robotic surgery training boosts team confidence, communication
- Perioperative leaders gather at 2025 OR Manager Conference
- CMS launches 6-year model to curb wasteful Medicare spending with AI-driven reviews
- Report: Hospitals can cut anesthesia costs, burnout through tech-driven partnerships
- Study: One in four US healthcare workers faces food insecurity
- Digital decision aid boosts shared decision-making in knee replacement consultations
- CMS narrows surveys to immediate jeopardy, harm during shutdown
- Ambient AI turns burnout relief into 'hard ROI' at Seattle Children’s
- Robotics redefine cardiac surgery with precision, smaller incisions, new frontiers in AI and telesurgery
- Private equity bets big on outpatient cardiology as CMS boosts reimbursements
© Access Intelligence, LLC. All rights reserved. |
Privacy Policy |
Cookie Settings |
Diversity, Equity, Inclusion & Belonging |
Accessibility Statement