O-arm 1000 2nd Edition Imaging System — Class II medical device recall Z-0277-2019
Terminated recall by Medtronic Navigation, Inc.-Littleton, reported 2018-10-31, distributed in AK, AL, AR, AZ, CA, CO, DC, DE…. Software anomalies were reported to affect the following system functionalities: startup and shutdown, system
| Recall number | Z-0277-2019 |
|---|---|
| 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 | 2018-08-30 |
| Classified | 2018-10-25 |
| Reported by FDA | 2018-10-31 |
| Terminated | 2020-06-18 |
| Distributed | AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI |
| Countries outside the US | AE, AT, AU, BE, BG, BH, BR, CA, CH, CL, CN, CY, CZ, DE, DK, EG, ES, FI, FR, GB, GR, HK, HR, IE, IL, IN, IT, JP, KR, KW, LB, MX, NL, NZ, PL, RU, SA, SE, SG, SK, TH, TR, TW, VE, ZA |
| Quantity | 596 total |
| Reason classes | software |
| Serial numbers | 1000, 2ND |
| Model numbers | 7230, BL7000002 |
Product
O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027230 SYSTEM 230V, Model Number Bl7000002 7230 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 0-arm Imaging System is compatible with certain Image Guided Surgery Systems.
Reason for recall
Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and output, dose reporting, and logs generation. Software version 3.1.7 will be installed on all 2nd edition imaging systems.
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-0277-2019. 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.