Recall Z-0552-2019 ยท HAW Neurological Stereotaxic Instrument
Medtronic Navigation, Inc.
StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide - Instructions for cranial procedures using optical localization StealthStation Cranial version 3.0, 3.1 CE 0344 Rx Only 2018-02 9735489 Revision 3 Medtronic Navigation, Inc. Biopsy Needle Kit (9733068) Note: This device is an accessory to your StealthStation System. . . The Biopsy Needle is a
| Date | Dec 29, 2018 (initiated Sep 26, 2018) |
| Status | Terminated |
| Reason | An incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View using Cranial software, which resulted in the biopsy of healthy tissue. |
| Root cause | Device Design |
| Action | On 09/26/2018, the firm sent an Urgent Medical Device Correction Notification to all US customers informing them of potential inaccuracy during biopsy procedures using the StealthStation S7 Depth Gauge feature on StealthStation S7 and i7 systems running Synergy Cranial and StealthStation Cranial software that could result in healthy tissue being biopsied. The notification letter stated, In navigated biopsy procedures, where the Navigate Projection feature is used and the projection is longer than the length of the plan, the graphical Biopsy Depth Gauge feature can display inaccurate informa |
| Quantity | 5487 impacted systems |
| Distribution | US: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, 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, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY OUS: Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Ba |
| FDA record | Open on fda.gov |