medical Class I Updated 2021-12-29

Medtronic Navigation, Inc. recalls Stealthstation System w/ Stealthstation Cranial Software 3.1

Recalled 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

Hazard / Issue

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.

Issued by

FDA

Affected States: 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

Lot/Code Info: 9733763, Version: 2.2.8; 9735585, Versions: 3.1.1, 3.1.2, 3.1.3

View official government recall

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