—#190392

Product

Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Cranial, Model: 9733763, and StealthStation Cranial, Model: 9735585

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K150216, K190672
Affected lot / code info: 9733763, Version: 2.2.8; 9735585, Versions: 3.1.1, 3.1.2, 3.1.3

Why it was recalled

Cranial biopsy procedure software can enter a state where the biopsy depth gauge is no longer synchronized with the rest of the navigational information on the screen and may display an incorrect position of the biopsy needle, which may result in prolonged procedure, the need for additional surgical procedure, tissue injury.

Root cause (FDA determination)

Software design

Action the firm took

On 11/11/21, correction notices were distributed to healthcare professionals. The recalling firm will provide a warning and instructional placard to be applied to impacted systems. Customers with questions are encouraged to call Technical Services for help at: 1-888-826-5603. Customers are asked to complete and return the confirmation form and maintain a copy of this correction notice. Until a software update is available, ensure you are following the instructions below to prevent the issue from occurring: Firm recommends NOT turning off Guidance View after locking the biopsy trajectory in the Cranial software. After locking trajectory for biopsy needle navigation, always ensure Guidance View remains an active view in at least one screen layout quadrant. If a discrepancy is detected between the biopsy depth gauge graphic and the other 2D information: 1) Obstruct the camera field of view of the biopsy needle or reference frame to cause red status. 2) Return to green status by no longer obstructing camera field of view of the biopsy needle and reference frame. 3) Use the Cycle Views icon to refresh guidance view and confirm that the biopsy depth gauge graphic matches the distance to target values and the position to target information provided by the 2D crosshairs. 4) Visually confirm accuracy before proceeding with navigation. Always Visually confirm navigational accuracy and confirm that the biopsy depth gauge graphic matches the distance to target values and matches the position to target information provided by the 2D crosshairs, which represent the tip position of the navigated instrument. Use the Biopsy Needle Mechanical Depth Stop. If system navigation seems inaccurate and steps to restore accuracy are unsuccessful, abort use of the system.

Recalling firm

Firm: Medtronic Navigation, Inc.
Address: 826 Coal Creek Cir, Louisville, Colorado 80027-9710

Distribution

Distribution pattern: US: MN, FL, MD, IL, AK, NE, NH, PA, ND, AR, CA, WI, NJ, GA, SD, AZ, KY, AL, MS, MO, TX, MI, MT, OH, NY, VA, MA, CT, TN, WV, WA, NC, CO, NV, ME, LA, DE, NM, IN, UT, DC, OR, SC, OK, IA, HI, ID, KS, WY, MN, PR OUS: AU, BN, GU, JP, KR, MY, NZ, SG, TH, VN, MM, CA, CZ, RU, AL, CY, DE, ES, FR, GB, HU, IL, IT, NL, PL, RO, CN, HK, TW, IN, LK, NP, AR, BB, BR, CL, CO, CR, DO, EC, MX, PE, PR, VE, NI, UY, AE, BH, DZ, EG, IQ, JO, KZ, KE, SA, LB, LY, MA, NA, PK, QA, ZA, TR, AT, BE, CH, DK, FI, GF, GR, IE, LV, LT, LU, PT, SE, SK, UK, BA, BG, CI, HR, RS, SI

Timeline

Recall initiated: 2021-11-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #190392. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.