Medtronic Navigation, Inc. recalls StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid f…

Recall date

June 5, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2707-2020

FDA classification

Class II

Brand / firm

Medtronic Navigation, Inc.

Sold / distributed

US Nationwide distribution including in the states of Alabama and Massachusetts.

Why it was recalled

There is a potential for specific camera units to be affected by a characterization issue during manufacturing that results in inaccurate navigation while utilizing both the active and passive trackers simultaneously. While no injuries or illnesses have been reported, If impacted cameras were to be used with both active and passive trackers simultaneously, it would result in system navigation inaccuracy of 6mm.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures.