FDA Device recall Z-1088-2016
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 fluoros…
- FDA Device
- Class II
- terminated
- Published 2016-03-16
On 2016-03-16 the FDA classified a Class II recall of 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 fluoros… by Medtronic Navigation, citing 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 bein….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1088-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-29 |
| Published | 2016-03-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Navigation |
| Distribution | n/a |
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.
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
Identifiers
| code_info | Serial Number: C0936 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1088-2016%22
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