Medtronic Navigation, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2707-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 5, 2020

Date Posted: August 5, 2020

Recall Number: Z-2707-2020

Event ID: 85901

Reason for Recall:

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.

Status: Terminated

Product Quantity: 2

Code Information:

StealthStation S7 Serial Number N06164844 with Polaris Spectra Camera Serial Number P7-01896; and StealthStation S7 Serial Number N07308697 with Polaris Spectra Camera Serial Number P7-18852.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated