Recall Z-1630-2023 ยท HAW Neurological Stereotaxic Instrument
Medtronic Navigation, Inc.
StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems
| Date | Jun 2, 2023 (initiated Apr 11, 2023) |
| Status | Open, Classified |
| Reason | During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic displays for cranial biopsy; causing displays to no longer synchronize with other navigational information showing inaccurate values, which may result in prolonged/additional procedure, tissue injury |
| Root cause | Software design |
| Action | On 4/11/23, correction notices were sent to healthcare professionals that were advised of the following; 1) Do not utilize the following: a) Biopsy Depth Gauge Graphic in Cranial Biopsy procedures. In accordance with the IFU: Frequently confirm navigation accuracy and system responsiveness during live navigation. Use the navigation instrument to touch several bony anatomical landmarks and confirm that the locations identified on the images match the locations touched on the patient. If accuracy degrades, re-register the patient. Always use the Biopsy Needle Mechanical Depth Stop. If system |
| Quantity | 746 |
| Distribution | Worldwide Distibution: US (nationwide): OH, IL, CA, MI, FL, LA, OK, WA, AR, NJ, MN, MO, WI, MA, ND, NY, MD, OR, AK, NE, TN, AZ, IN, GA, GU, VA, PA, TX, SD, MT, NV, MS, KY, AL, CT, WV, KS, IA, NC, UT, CO, NH, DC, WY. OUS (foreign): ALBANIA, ARGENTINA, Australia, AUSTRIA, BANGLADESH, BARBADOS, BELGIU |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K221087 | Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 Medtronic Navigation, Inc., Jun 10, 2022 |