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.
FDA Recall Z-0715-2011 · Posted 2010-12-17
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Recalling FirmMedtronic Navigation, Inc
Recall StatusTerminated
Product CodeHAW
Date Initiated2010-11-05
Date Terminated2011-05-03
Product Quantity48 devices
Reason for Recall
Electronic surgical navigation aid may lose tracking ability or stop working.
Firm 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.
Root Cause
Component design/selection
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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