StealthStation S8 Application version 2.0 and 2.0.1 recall: Software Issue
StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is intended as an…
Why was StealthStation S8 Application version 2.0 and 2.0.1 recalled?
Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: 9735762 UDI-DI Code: 00763000532123 Software Versions 2.0 and 2.0.1 All systems with the impacted software version regardless of how it was purchased Updated list of Product Models/Serial provide on 06/06/2024 and was uploaded to Associated Documents.
- Product
- StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is intended as an…
- Recalling firm
- Medtronic Navigation, Inc.
- Quantity
- 5,240 affected systems
- Distribution
- Worldwide Distribution: U.S. (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. O.U.S.(foreign) including countries of: ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BRAZIL, BULGARIA, CANADA, CANARY ISLANDS, CHILE, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, FRENCH POLYNES, GERMANY, GREECE, HONG KONG, HUNGARY, ICELAND, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KAZAKHSTAN, KENYA, KOREA, KUWAIT, LATVIA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PANAMA, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIAN FEDERATION, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UKRAINE, and UNITED KINGDOM
- Recall date
- November 15, 2023
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)