FDA Device recall Z-0928-2018
O-arm 1000 mobile image-intensified fluoroscopic x-ray system
- FDA Device
- Class II
- terminated
- Published 2018-03-14
On 2018-03-14 the FDA classified a Class II recall of O-arm 1000 mobile image-intensified fluoroscopic x-ray system by Medtronic Navigation Littleton, citing 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 reco….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0928-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-25 |
| Published | 2018-03-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Navigation Littleton |
| Distribution | US |
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
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.
Identifiers
| code_info | Serial Numbers: B14070845 B13050682 B13080716 B14010771 B14010779 B14020790 B14040813 B15020929 B14020789 B151…Serial Numbers: B14070845 B13050682 B13080716 B14010771 B14010779 B14020790 B14040813 B15020929 B14020789 B15101034 B15101041 B16011100 B16021102 B15060987 B14110904 B16021105 B16021106 B15020941 B15050972 B15030949 B16021111 B15091028 B14010774 B14030797 B16021112 B16031114 B16041137 B16061190 B15010926 B15060988 B16061196 B13080721 B16071207 B16071213 B13080722 B16071215 B16081234 B17101333 B14030803 B14040814 B17101445 B14040817 B17071466 B17121536 B14050830 B17121544 B14050829 B14070857 B14080865 B14090881 B13080718 B14050824 B14060833 B13060683 B13060698 B15030948 B15050971 B14010781 B14030802 B14030805 B15121072 B16011082 B13090723 B13120770 B14010772 B13120764 B14010776 B14030785 B14110898 B14120906 B14030807 B14050823 B14060832 B14060834 B16111259 B15020925 B15091014R B17031257 B13080717 B14010775R B15091020 B14040811 B14050822 B14070840 B15030946 B14030808 B13080724 B14070851 B14020773 B14 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0928-2018%22
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