Recall Z-0383-2022 ยท HAW Neurological Stereotaxic Instrument
Medtronic Navigation, Inc.
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
| Date | Nov 11, 2021 |
| Status | Open, Classified |
| Reason | 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 | Software design |
| Action | 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 th |
| Quantity | 2587 |
| Distribution | 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, |
| FDA record | Open on fda.gov |