Stealthstation System w/ Stealthstation Cranial recalled

Timeline

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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, IT, NL, PL, RO, CN, HK, TW, IN, LK, NP, AR, BB, BR, CL, CO, CR, DO, EC, MX, PE, PR, VE, NI, UY, AE, BH, DZ, EG, IQ, JO, KZ, KE, SA, LB, LY, MA, NA, PK, QA, ZA, TR, AT, BE, CH, DK, FI, GF, GR, IE, LV, LT, LU, PT, SE, SK, UK, BA, BG, CI, HR, RS, SI

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