Polaris Spectra System Control Unit, a component of the StealthStation S7 System. Medtronic Navigation, Louisville, CO 8
FDA device recall Z-0715-2011 · posted 2010-12-17 · Terminated
Recall details
- Recalling firm
- Medtronic Navigation, Inc
- Reason for recall
- Electronic surgical navigation aid may lose tracking ability or stop working.
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- HAW
- Quantity affected
- 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, Portug
- Date initiated
- 2010-11-05
- Date posted
- 2010-12-17
- Date terminated
- 2011-05-03
- Location
- Louisville, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STEALTHSTATION SYSTEM UPDATE (K050438) | Medtronic Surgical Navigation Technologies | 2005-06-02 |