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U.S. Department of Health and Human Services

Class 2 Device Recall Polaris Spectra Camera for StealthStation S7 System

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  Class 2 Device Recall Polaris Spectra Camera for StealthStation S7 System see related information
Date Initiated by Firm June 05, 2020
Create Date July 27, 2020
Recall Status1 Completed
Recall Number Z-2707-2020
Recall Event ID 85901
510(K)Number K133444  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
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.
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.
Recalling Firm/
Manufacturer		 Medtronic Navigation, Inc.
826 Coal Creek Cir
Louisville CO 80027-9710
For Additional Information Contact
720-890-3200
Manufacturer 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Urgent Medical Device Correction Letters were emailed to customers on June 5, 2020. Emails were followed by Medtronic representatives hand-delivering the recall notification letter as well as the customer confirmation form to the two affected consignees on June 12, 2020. Customers were informed that 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. Customers were informed that their local Medtronic representative would work with them to remove and replace the affected camera on your impacted system. Customers were informed that Medtronic has not identified any complaints or reports of injury related to this issue. However, if impacted cameras were to be used with both active and passive trackers simultaneously, it would result in system navigation inaccuracy of 6mm. Customers were requested to not use the affected StealthStation" S7 System unit for simultaneous active and passive navigation (such as active instrumentation, active reference frames, or a navigated microscope) until the camera is replaced on this system; to work with their Medtronic representative to replace the camera on their impacted system; and to sign and return the enclosed customer confirmation form, acknowledging receipt of this information.Customers were notified that Medtronic is communicating this information to the Food and Drug Administration (FDA). Adverse events or quality problems experienced with this product should be reported to FDA and Medtronic: Online at the FDA website (www.fda.gov) or call FDA at 1-800-FDA-1088 and via E-mail to Medtronic at rs.navtechsupport@medtronic.com or by calling 1-888-826-5603. Customers with any questions regarding the urgent medical device correction should contact Medtronic Technical Services at 1-888-826-5603.
Quantity in Commerce 2
Distribution US Nationwide distribution including in the states of Alabama and Massachusetts.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HAW and Original Applicant = MEDTRONIC NAVIGATION, INC.
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