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.
This recall has been terminated (originally issued December 17, 2010).
- Company
- Medtronic Navigation, Inc.
- Recall Initiated
- November 5, 2010
- Posted
- December 17, 2010
- Terminated
- May 3, 2011
- Recall Number
- Z-0715-2011
- Quantity
- 48 devices
- Firm Location
- Louisville, CO
- Official Source
- View on FDA website ↗
Reason for Recall
Electronic surgical navigation aid may lose tracking ability or stop working.
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.
Lot / Code Info
Lots received from NDI (supplier) between May 1, 2020, and July 31, 2010.
Root Cause
Component design/selection
Action Taken
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.