Recall Z-0188-2024— Medtronic Navigation, Inc.
Class I · Ongoing
Class I FDA medical device recall by Medtronic Navigation, Inc., initiated 2023-09-27. It names one FDA 510(k) clearance: K212397. Product: StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. The StealthStation FlexENT System, with StealthStation ENT software, is intended as an aid for locating anatomical structures in either open or percutaneous ENT procedures.. Reason: Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location..
- Recalling firm
- Medtronic Navigation, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2023-09-27
- Firm location
- Lafayette, CO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. The StealthStation FlexENT System, with StealthStation ENT software, is intended as an aid for locating anatomical structures in either open or percutaneous ENT procedures.
Reason for recall
Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location.
Data sourced from openFDA. This site is unofficial and independent of the FDA.