Recall Z-0188-2024 ยท HAW Neurological Stereotaxic Instrument
Medtronic Navigation, Inc.
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 percut
| Date | Nov 10, 2023 (initiated Sep 27, 2023) |
| Status | Open, Classified |
| Reason | Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location. |
| Root cause | Software design |
| Action | On 09/27/2023, the firm sent an "URGENT: MEDICAL DEVICE CORRETION" Letter/Communication via UPS to customer informing them of a software anomaly affecting certain StealthStation S8 and StealthStation FlexENT system with the StealthStation S8 App software version 2.0 and 2.0.1. Due to the software anomaly, there is the potential for the surgical planning data to encounter a displayed shift which could result in proceeding to an incorrect location from the planned target. This result in unintended tissue damage leading to permanent neurological injury, additional pass of device (biopsy needle |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K212397 | StealthStation S8 Cranial v2.0 Medtronic Navigation, Dec 22, 2021 |