Synergy Spine. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as the skull, a long bod, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
This recall has been terminated (originally issued July 18, 2016).
- Company
- Medtronic Navigation, Inc.
- Recall Initiated
- July 18, 2016
- Terminated
- December 1, 2016
- Recall Number
- Z-2316-2016
- Quantity
- 27 in total
- Firm Location
- Louisville, CO
- Official Source
- View on FDA website ↗
Reason for Recall
Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.
Distribution
Worldwide Distribution - US Nationwide in the state of: NY, AZ, AR, NC, CA, OH, MI, IN, MA, TX, OH, OR, CO, MO, UT, IL. and the countries of: India, Australia, and Russian Federation.
Lot / Code Info
Model Number 9733686-02. All lot numbers manufactured by Medtronic Navigation are affected.
Root Cause
Software design
Action Taken
Medtronic sent an Urgent Medical Device Safety Alert to all affected customers on August 20, 2016. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached confirmation form and return to RS.NavFCA@medtronic.com or fax it to Medtronic Technical Service at 651-367-7075. For questions contact Neurologica Technical Support at 1-888-564-8561 (US/Canada) or +1-978-564-8561 (International) or email support@neurologica.com