StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems

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

Code information: Model/UDI-DI; Software Version: 9735585/00763000631635, 9735586/00763000631765, 9735587/00763000631826; 3.1.4

Distribution pattern: 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, BELGIUM, Bosnia and Herzegovina, BULGARIA, CANADA, CHILE, CROATIA, CZECH REPUBLIC, DENMARK, FRANCE, GREECE, INDIA, IRELAND, ITALY, JAPAN, LUXEMBOURG, MARTINIQUE, NEW ZEALAND, POLAND, PORTUGAL, Republic of Korea, ROMANIA, RUSSIAN FEDERATION, SINGAPORE, SLOVAKIA, SPAIN, SWITZERLAND, TAIWAN, Turkey, UNITED ARAB EMIRATES, UNITED KINGDOM