FDA Device recall Z-1932-2019
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…
- FDA Device
- Class II
- terminated
- Published 2019-07-10
On 2019-07-10 the FDA classified a Class II recall of 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… by Medtronic Navigation Littleton, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1932-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-05-01 |
| Published | 2019-07-10 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medtronic Navigation Littleton |
| Distribution | US |
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
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
Identifiers
| code_info | Serial Numbers: US: 00102 00103R 00105 00112R 00113 00116R 00117R 00118R 00126 00128R 00129 00131 00133 0…Serial Numbers: US: 00102 00103R 00105 00112R 00113 00116R 00117R 00118R 00126 00128R 00129 00131 00133 00134 00135 00138 00140 00147 00148 00149 00152 00157 00158 00164R 00167 00168 00170 00171 00173 00176 00178 00179 00182 00184R 00185 00186 00188 00189 00190 00191 00199 00202 00205 00210R 00211 00212 00214 00215 00218 00219 00221 00222 00224 00225 00226 00229 00232R 00234R 00235 00236 00238R 00239 00242 00248 00256 00257 00261 00262 00267 00269 00270 00273 00274R 00275 00277 00280 00282 00288 00289R 00293 00294 00296 00297 00300 00305 00306R 00307 00308 00309R 00311 00312R 00313 00314 00315 00317 O-Arm 318 00319R 00333 00335 00341 00342 00343 00344 00347 00348 00350 00351 00359 00360 00362 00363 00365 00366 00369 00370 00373 00377 00378 00379 00381 00383 00385 00391 00392 00394 00396 00398 00399 00400 00401 00404 00405 00406 00408 00409 00410 00412 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1932-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.