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U.S. Department of Health and Human Services

Class 2 Device Recall Polaris Spectra System Control Unit

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  Class 2 Device Recall Polaris Spectra System Control Unit see related information
Date Initiated by Firm November 05, 2010
Date Posted December 17, 2010
Recall Status1 Terminated 3 on May 03, 2011
Recall Number Z-0715-2011
Recall Event ID 57277
510(K)Number K050438  
Product Classification Neurological Stereotaxic Instrument - Product Code HAW
Product Polaris Spectra System Control Unit, a component of the StealthStation S7 System. Medtronic Navigation, Louisville, CO 80027.

Intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures.
Code Information Lots received from NDI (supplier) between May 1, 2020, and July 31, 2010.
Recalling Firm/
Manufacturer		 Medtronic Navigation, Inc
826 Coal Creek Circle
Louisville CO 80027-9710
For Additional Information Contact
720-890-3217
Manufacturer Reason
for Recall		 Electronic surgical navigation aid may lose tracking ability or stop working.
FDA Determined
Cause 2		 Component design/selection
Action Customers were notified by a Product Correction Notification letter on 11/05/2010. The letter advised customers of the affected product, the potential problem, and the description of the correction. Customers were told that a Medtronic rep will visit them to install a replacement control unit. Further information is available at 800-595-9709 or 720-890-3200.
Quantity in Commerce 48 devices
Distribution Worldwide Distribution -- US, including states of AL, AZ, CO, FL, GA, KY, MD, MN, NE, PA, TX, WI, and MD and countries of Australia, Belgium, Canada, Czech Republic, Italy, Netherlands, Poland, Portugal, Saudi Arabia, Singapore, South Korea, Spain, Turkey, and UAE.
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.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HAW and Original Applicant = MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES
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