O-arm" O2 Imaging System — Class II medical device recall Z-0767-2020
Terminated recall by Medtronic Navigation, Inc.-Littleton, reported 2020-01-08, distributed in AR, CA, CO, CT, FL, ID, IL, IN…. Due to a manufacturing issue affecting particular O-arm" O2 Imaging Systems, Medtronic has determined that the
| Recall number | Z-0767-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc.-Littleton, Littleton, MA, United States |
| Recall initiated | 2019-11-15 |
| Classified | 2019-12-31 |
| Reported by FDA | 2020-01-08 |
| Terminated | 2023-09-19 |
| Distributed | AR, CA, CO, CT, FL, ID, IL, IN, KS, KY, MI, MN, MO, NC, ND, NE, NY, OH, OR, PA, SC, SD, TX, VA, WA, WI, WV |
| Countries outside the US | AU, CA, CH, CN, DE, ES, FR, GB, IN, IT, JP, LB, NL, RO, SA, SE |
| Quantity | 90 |
| UPC / GTIN / UDI-DI | 00763000074050, 00763000074067, 00763000074098, 00763000074104, 00763000074128, 00763000074135, 00763000081003, 00763000081041, 00763000081102, 00763000132378, 00763000134488, 00763000134518, 00763000135829, 00763000135836, 00763000168605 |
Product
O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000
Reason for recall
Due to a manufacturing issue affecting particular O-arm" O2 Imaging Systems, Medtronic has determined that the gantry tractor motor drive belt may loosen over an extended number of uses at a higher frequency in these systems. If the belt loosens, it may result in rotation of 3D images about the gantry isocenter. While the 3D image is anatomically accurate within the image itself and may be used to confirm therapy, its electronic registered location may be rotated relative to the actual physical position of the patient.
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-0767-2020. 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.