Medtronic Navigation, Inc. recalls Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid fo

Recalled May 15, 2024 · FDA recall Z-1776-2024 · Medtronic Navigation

Hazard

Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation. · FDA Class I

Units

3286 applications.

Sold at

Worldwide distribution. US nationwide including Puerto Rico, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, El Salvador, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Republic Of Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Malaysia, Martinique, Mexico, Morocco, Netherlands, Nicaragua, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.

Description

Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation.

Product

Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures.

Manufacturer(s)

Medtronic Navigation, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →