Medtronic Navigation, Inc.: 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 pe

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.

Details from the source

Reason for recall: 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. Distribution: 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, Quantity: 3286 applications. Lot/code info: UDIs: 00763000234867, 00763000125295, 00763000063177, 00643169865341/ Software Versions: 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1.

UPC codes

00763000234867, 00763000125295, 00763000063177, 00643169865341

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.