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Medtronic Navigation, Inc. recalls StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid fo
Recalled August 5, 2020 · FDA recall Z-2707-2020 · Medtronic Navigation
Hazard
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. · FDA Class II
Units
2
Sold at
US Nationwide distribution including in the states of Alabama and Massachusetts.
Description
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.
Product
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.
Manufacturer(s)
Medtronic Navigation, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →