Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and… — Class II medical device recall Z-1932-2019
Terminated recall by Medtronic Navigation, Inc.-Littleton, reported 2019-07-10, distributed nationwide. The 0-arm 1000 Imaging System uses energy from the batteries to generate X-rays and move the system. If a char
| Recall number | Z-1932-2019 |
|---|---|
| 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 | 2019-05-01 |
| Classified | 2019-07-03 |
| Reported by FDA | 2019-07-10 |
| Terminated | 2021-01-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, BH, BR, CA, CH, CL, CN, CO, CZ, DE, DK, DZ, EG, ES, FI, FR, GB, GR, HK, HR, IE, IL, IN, IT, JO, JP, KR, KW, LB, MX, NI, NL, NZ, PL, PT, SA, SE, SG, SK, TH, TR, TW, VE, ZA |
| Quantity | 832 units |
| Serial numbers | 00102, 00103R, 00105, 00110R, 00112R, 00113, 00116R, 00117R, 00118R, 00119, 00121, 00122, 00125, 00126, 00128R, 00129, 00131, 00133, 00134, 00135, 00138, 00139, 00140, 00143, 00144 and 475 more |
| Model numbers | BI70000027GERR, BI70000028120R, BL70000028230R |
Product
Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XXX (where XXX indicates the system voltage): Product Name Model#/ CFN OARM ASSY 8170000027 SYSTEM PRODUCT BI70000027 OARM ASSY BI70000027R SYS PRODUCT RWK BI70000027R BASE OARM 8170000027100 SYSTEM !DOV BI70000027100 BASE OARM Bl70000027100R SYSTEM lOOV RWK Bl70000027100R BASE OARM 8170000027120 SYSTEM 120V 8170000027120 BASE OARM Bl70000027120R SYSTEM 120V RWK BI70000027120R BASE OARM Bl70000027230 SYSTEM 230V 8170000027230 BASE OARM Bl70000027230R SYSTEM 230V RWK BI70000027230R OARM ASSY BI70000027GER SYS PRODUCT GER BI70000027GER OARM ASSY Bl70000027GERR SYS PRODUCT REFURB BI70000027GERR BASE OARM 8170000028100 SYS lOOV 8170000028100 BASE OARM BI70000028120 SYS 120V 8170000028120 BASE OARM BI70000028120R 3RD EDIT REFURB BI70000028120R BASE OARM BI70000028230 SYS 230V BI70000028230 BASE OARM BI70000028230R 3RD EDIT REFURB Bl70000028230R Product Usage: The 0-arrn 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 anatomi~ 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
The 0-arm 1000 Imaging System uses energy from the batteries to generate X-rays and move the system. If a charger board is not functioning properly, the batteries will not receive a full recharge of the potential capacity and results in the inability of the system to take X-rays, open the gantry, and move the system from one place to another, which may affect the ability to continue use within the operating room until the charger board and/or the batteries are replaced
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.