FDA Enforcement
Class II
Terminated
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.
Recall: Z-1088-2016
·
Reported March 16, 2016
Enforcement
- Recall Number
- Z-1088-2016
- Event ID
- 73303
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Medtronic Navigation, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 16, 2016
- Initiation Date
- January 29, 2016
- Classification Date
- March 8, 2016
- Termination Date
- March 10, 2016
- Address
- 300 Foster St, N/A, Littleton, MA, 01460-2017, United States
Description
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.
Reason
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
Code Info
Serial Number: C0936
Distribution
Worldwide Distribution to Austria only.
Quantity
1 unit