FDA Device recall Z-0926-2013
Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile
- FDA Device
- Class II
- terminated
- Published 2013-03-20
On 2013-03-20 the FDA classified a Class II recall of Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile by Medtronic Navigation, citing potential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0926-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-01-31 |
| Published | 2013-03-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Navigation |
| Distribution | US |
Product
Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile
Reason
Potential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction
Identifiers
| code_info | Product Catalog Numbers: 9732719, 9732719R, 9733346, 9733346R, BI-700-00027, BI-700-00027R, BI-700-00027-GER, BI-700-0…Product Catalog Numbers: 9732719, 9732719R, 9733346, 9733346R, BI-700-00027, BI-700-00027R, BI-700-00027-GER, BI-700-00027-GERR, BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R Units with serial numbers 101 through 564 and unit 580 are affected. Serial numbers 565 and higher are not affected . |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0926-2013%22
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