—#148277

Product

MACH AxiEM Cranial Treon. 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.

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K001284
Affected lot / code info: Model Number 9730889. All lot numbers manufactured by Medtronic Navigation are affected.

Why it was recalled

Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners.

Root cause (FDA determination)

Software design

Action the firm took

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

Recalling firm

Firm: Medtronic Navigation, Inc.
Address: 826 Coal Creek Cir, Louisville, Colorado 80027-9710

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2016-07-18
Terminated: 2016-12-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #148277. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.