Medtronic Navigation, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2315-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

S7 MACH FrameLink. 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.

Product Classification:

Class II

Date Initiated: July 18, 2016

Date Posted: August 10, 2016

Recall Number: Z-2315-2016

Event ID: 74715

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.

Status: Terminated

Product Quantity: 27 in total

Code Information:

Model Number 9733986 . All lot numbers manufactured by Medtronic Navigation are affected.

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.

Voluntary or Mandated:

Voluntary: Firm initiated