—#143801

Product

Medtronic 0-arm 02 Imaging System Catalog Number: Bl-700-02000 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The O-arm O2 Imaging System is compatible with certain image guided surgery systems.

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K151000
Affected lot / code info: Serial Number: C0936

Why it was recalled

Screws holding the detector panel in as a result the detector panel could make contact with other parts with in the 0-arm 02 Imaging System, causing noise and vibration when being positioned or during 3D Imaging could lead to poor image quality

Root cause (FDA determination)

Process control

Action the firm took

Medtronic Navigation issued a Field Safety Notice dated January 29, 2016, to notify them of a hardware correction in the unit. A Medtronic service representative will service the system and arrange for an inspection of the system. This representative will properly torque the eight (8) screws if they find them to be loose. In the meantime, if noise or vibration are observed during use of the system customers should contact their Medtronic representative to report the issue. Customers with questions were instructed to call 720-890-3160. For questions regarding this recall call 978-698-6000.

Recalling firm

Firm: Medtronic Navigation, Inc.
Address: 300 Foster St, Littleton, Massachusetts 01460-2017

Distribution

Distribution pattern: Worldwide Distribution to Austria only.

Timeline

Recall initiated: 2016-01-29
Posted by FDA: 2016-03-08
Terminated: 2016-03-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #143801. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.