Recall Z-2313-2016— Medtronic Navigation, Inc.

Name: FDA recall Z-2313-2016
Creator: U.S. Food and Drug Administration
Published: 2016-07-18

Class II · Terminated

Class II FDA medical device recall by Medtronic Navigation, Inc., initiated 2016-07-18, terminated 2016-12-01. It names one FDA 510(k) clearance: K050438. Product: Synergy Cranial S7. 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.. Reason: Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners..

Recalling firm: Medtronic Navigation, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-07-18
Terminated: 2016-12-01
Firm location: Louisville, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K050438 — STEALTHSTATION SYSTEM UPDATEMedtronic Surgical Navigation Technologies·cleared 2005-06-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Synergy Cranial S7. 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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.