O-arm 1000 mobile image-intensified fluoroscopic x-ray system — Class II medical device recall Z-0928-2018
Terminated recall by Medtronic Navigation, Inc.-Littleton, reported 2018-03-14, distributed nationwide. Software update ("SW Update 3.2.1") is being implemented to address the following issues: Inability to power t
| Recall number | Z-0928-2018 |
|---|---|
| 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 | 2018-01-25 |
| Classified | 2018-03-08 |
| Reported by FDA | 2018-03-14 |
| Terminated | 2019-04-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, CH, CL, CN, CZ, DE, DZ, ES, FI, FR, GB, GR, IL, IN, JO, LB, LK, NI, NZ, PL, PT, RU, SA, SG, TH |
| Quantity | 253 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00643169353411, 00643169353459, 00643169353992, 00643169354081, 00643169354418 |
| Serial numbers | 804, 831, 842, B13050681, B13050682, B13050685, B13060683, B13060698, B13070710, B13080711, B13080715, B13080716, B13080717, B13080718, B13080719, B13080720, B13080721, B13080722, B13080724, B13090723, B13090729, B13120763, B13120764, B13120765, B13120766 and 228 more |
Product
O-arm 1000 mobile image-intensified fluoroscopic x-ray system; (1) Model: BASE OARM Bl70000028100 SYS 100V, Product Number: Bl70000028100 (UDI: 00643169354418); (2) Model: BASE OARM Bl70000028120 SYS 120V, Product Number: Bl70000028120 (UDI: 00643169353411); (3) Model: BASE OARM Bl70000028120R SYS 120V RWK, Product Number: Bl70000028120R (UDI: 00643169353459); (4) Model: BASE OARM Bl70000028230 SYS 230V, Product Number: Bl70000028230 (UDI: 00643169353992); (5) BASE OARM Bl70000028230R SYS 230V RWK, Product Number: Bl70000028230R (UDI: 00643169354081) Product Usage: The O-arm 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 Imaging System is compatible with certain Image Guided Surgery Systems.
Reason for recall
Software update ("SW Update 3.2.1") is being implemented to address the following issues: Inability to power the system after shutdown, System stays in standalone mode, Image reconstruction, System/Pendant bootup, Dose display/report, Gantry motion, Network communication, System shutdown, and Early termination of 3D spin.
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-0928-2018. 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.