Medtronic Navigation, Inc. Recall: StealthStation Cranial and Synergy Cranial Depth Gauge:
Medtronic Navigation, Inc. Recall: StealthStation Cranial and Synergy Cranial Depth Gauge: is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Medtronic Navigation, Inc.; Product: StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide - Instruct
| Recalling firm | Medtronic Navigation, Inc. |
|---|---|
| Product | 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 presterilized , single-use, side-cutting needle for cranial tissue biopsies. CE 0344 Rx Only 2017-05 9733068-01 Medtronic Navigation, Inc. |
| Reason for recall | 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. |
| Classification | Class I (most serious — reasonable probability of serious health consequences or death) |
| Status | Terminated |
| 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, Bar |
| Recall initiated | 20180926 |
| Recall number | Z-0552-2019 |
| Category | device |
| State | CO |
| Country | United States |
$29/mo
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