FDA Device recall Z-0261-2018
Mobile Mini C-arm system Part # 1000-0004-FD. Intended to provide the physician with general fluoroscopic visualization of the patient, inc…
- FDA Device
- Class II
- terminated
- Published 2018-01-17
On 2018-01-17 the FDA classified a Class II recall of Mobile Mini C-arm system Part # 1000-0004-FD. Intended to provide the physician with general fluoroscopic visualization of the patient, inc… by Orthoscan, citing orthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0261-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-31 |
| Published | 2018-01-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Orthoscan |
| Distribution | US |
Product
Mobile Mini C-arm system Part # 1000-0004-FD. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.
Reason
OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital Zoom feature in the course of taking a live image exposing a larger x-ray field than can be viewed by the user
Identifiers
| code_info | Serial Number List: 5E1290 5H0178 5H0125 5E833 5E1164 5F0395 5E730 5E105 5H0126 5E921 5E742 5F0400 5E756 5E0940 5H…Serial Number List: 5E1290 5H0178 5H0125 5E833 5E1164 5F0395 5E730 5E105 5H0126 5E921 5E742 5F0400 5E756 5E0940 5H0130 5F0126 5F0282 5F0412 5E763 5E0943 5H0151 5F0229 5H0273 5F0441 5E841 5E0961 5H0172 5F0230 5E0944 5F0449 5F0232 5E0981 5H0190 5F0387 5E0945 5F0451 5H0291 5E0982 5H0333 5F0445 5E0955 5F0456 5F0177 5E1009 5E0954 5F0453 5E1000 5F0468 5F0242 5E1042 5E1043 5F0457 5E1025 5F0471 5F0295 5E1051 5E1234 5F0465 5E1177 5F0482 5H0265 5E1063 5E1280 5F0610 5E1185 5F0495 5H0292 5E1080 5E908 5H0104 5E1225 5F0497 5E0938 5E1141 5F0158 5H0114 5E1249 5F0517 5E0990 5E1151 5F0408 5E1174 5E1265 5F0533 5E1021 5E1224 5F0519 5E1232 5E1276 5F0537 5E1032 5E1233 5H0272 5E846 5E1279 5F0548 5E1086 5E1266 5H0290 5E1137 5E1288 5F0594 5E1087 5E1269 5E0998 5E1257 5E734 5F0603 5E1105 5E1284 5E1033 5E1176 5E744 5F0621 5E1115 5E1293 5E1035 5E1178 5E772 5F0626 5E1150 5E1315 5E1047 5E1197 5E775 5F0630 5E1261 5E1316 5E1082 5E1303 5E818 5F0631 5E1287 5E739 5E1242 5E769 5E822 5F0632 5E1292 |
|---|
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-0261-2018%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.