02

Jun

2023

FDA Recall: Software Anomalies Cause Displays to Not Synchronize with Navigational Information

0

Company: Medtronic Navigation, Inc.
Date of Enforcement Report: 06/02/2023
Class I

PRODUCT

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

Recall Number:

Z-1630-2023

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

RECALLING FIRM/MANUFACTURER:

Medtronic Navigation, Inc.

VOLUME OF PRODUCT IN COMMERCE:

746

DISTRIBUTION:

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

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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