Medtronic O-arm Imaging System Product Usage: image-intensified… — Class II medical device recall Z-0926-2013
Terminated recall by Medtronic Navigation, Inc., reported 2013-03-20, distributed nationwide. Potential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical
| Recall number | Z-0926-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc., Littleton, MA, United States |
| Recall initiated | 2013-01-31 |
| Classified | 2013-03-08 |
| Reported by FDA | 2013-03-20 |
| Terminated | 2016-07-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BE, BG, BR, CA, CH, CL, CN, CZ, DE, DK, ES, FI, FR, GB, GR, HR, IE, IL, IN, IT, JP, KR, KW, LB, MX, NL, NZ, PL, SA, SE, SG, SK, TH, TR, TW, ZA |
| Quantity | 463 units |
| Serial numbers | 101, 565 |
| Model numbers | 9732719, 9732719R, 9733346, 9733346R, BI-700-00027, BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R, BI-700-00027-GER, BI-700-00027-GERR, BI-700-00027R |
Product
Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile
Reason for recall
Potential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction
Machine access
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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.