Medtronic 0-arm 02 Imaging System Catalog Number: Bl-700-02000 The… — Class II medical device recall Z-1088-2016
Terminated recall by Medtronic Navigation, Inc., reported 2016-03-16. Screws holding the detector panel in as a result the detector panel could make contact with other parts with i
| Recall number | Z-1088-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc., Littleton, MA, United States |
| Recall initiated | 2016-01-29 |
| Classified | 2016-03-08 |
| Reported by FDA | 2016-03-16 |
| Terminated | 2016-03-10 |
| Countries outside the US | AT |
| Quantity | 1 units |
| Serial numbers | C0936 |
| Model numbers | BL-700-02000 |
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 for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1088-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.