Recall Z-0715-2011 ยท HAW Neurological Stereotaxic Instrument
Medtronic Navigation, Inc
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.
| Date | Dec 17, 2010 (initiated Nov 5, 2010) |
| Status | Terminated |
| Reason | Electronic surgical navigation aid may lose tracking ability or stop working. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050438 | STEALTHSTATION SYSTEM UPDATE Medtronic Surgical Navigation Technologies, Jun 2, 2005 |