Medtronic Navigation, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1630-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: April 11, 2023

Date Posted: June 14, 2023

Recall Number: Z-1630-2023

Event ID: 92141

Reason for Recall:

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

Status: Ongoing

Product Quantity: 746

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

Voluntary or Mandated:

Voluntary: Firm initiated