O-arm¿ O2 interventional fluoroscopic x-ray system — Class II medical device recall Z-0927-2018
Terminated recall by Medtronic Navigation, Inc.-Littleton, reported 2018-03-14, distributed nationwide. During servicing of certain internal components of the O-Arm O2 Surgical Imaging System, it is possible that t
| Recall number | Z-0927-2018 |
|---|---|
| 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 | 2017-09-30 |
| Classified | 2018-03-08 |
| Reported by FDA | 2018-03-14 |
| Terminated | 2019-05-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, BE, BR, CA, CH, CL, CN, CO, CZ, DE, DK, ES, FI, FR, GB, HR, IE, IL, IN, IS, IT, JO, JP, KR, LU, MX, NL, NZ, PL, PT, QA, RO, SA, SE, SG, TH, TR, TW, ZA |
| Quantity | 449 |
| Serial numbers | 1065R, C0875, C0876, C0877, C0878, C0879, C0930, C0931, C0932, C0933, C0934, C0935, C0936, C0962, C0963, C0964, C0965, C0966, C0967, C0973, C0974, C0977, C0978, C0981, C0982 and 475 more |
| Model numbers | B1-700-02000 |
Product
O-arm¿ O2 interventional fluoroscopic x-ray system; Catalog Number: B1-700-02000 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighting 60 lbs or greater and having an abdominal thickness of greater than 16cm, 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
During servicing of certain internal components of the O-Arm O2 Surgical Imaging System, it is possible that the high-power cable connector may come in contact with surrounding metal during the disconnecting/reconnecting process which may result in an electrical short and a shock to the field service technician.
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.