FDA Device recall Z-0927-2018
O-arm¿ O2 interventional 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¿ O2 interventional fluoroscopic x-ray system by Medtronic Navigation Littleton, citing during servicing of certain internal components of the O-Arm O2 Surgical Imaging System, it is possible that the high-power cable connector may come in contact with surrounding me….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0927-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-30 |
| Published | 2018-03-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Navigation Littleton |
| Distribution | US |
Product
O-arm¿ O2 interventional fluoroscopic x-ray system; Catalog Number: B1-700-02000 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighting 60 lbs or greater and having an abdominal thickness of greater than 16cm, 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 O2 Imaging System is compatible with certain image guided surgery systems.
Reason
During servicing of certain internal components of the O-Arm O2 Surgical Imaging System, it is possible that the high-power cable connector may come in contact with surrounding metal during the disconnecting/reconnecting process which may result in an electrical short and a shock to the field service technician.
Identifiers
| code_info | Serial Numbers: 1065R C0875 C0876 C0877 C0878 C0879 C0930 C0931 C0932 C0933 C0934 C0935 C0936 C0962 C0963…Serial Numbers: 1065R C0875 C0876 C0877 C0878 C0879 C0930 C0931 C0932 C0933 C0934 C0935 C0936 C0962 C0963 C0964 C0965 C0966 C0967 C0973 C0974 C0977 C0978 C0981 C0982 C0985 C0986R C0989 C0990 C0993 C0994R C0997 C0998 C1001 C1002 C1007 C1010 C1011 C1013 C1015 C1016 C1021 C1022 C1025 C1027 C1029 C1031 C1033 C1035 C1036 C1037 C1038 C1040 C1042 C1043 C1044 C1045 C1046 C1047 C1050 C1051 C1052 C1053 C1054 C1056 C1057 C1059 C1060 C1061 C1062 C1063 C1066 C1067 C1068 C1069 C1070 C1071 C1073 C1074 C1075 C1076 C1077 C1079 C1080 C1081 C1083 C1084 C1085 C1086 C1087 C1089 C1090 C1091 C1092 C1094 C1096 C1097 C1098 C1099 C1101 C1103 C1104 C1107 C1108 C1109 C1110 C1113 C1116 C1117 C1121R C1123 C1124 C1125 C1127 C1128 C1129 C1131 C1132 C1133 C1134 C1135 C1139 C1140 C1141 C1142 C1143 C1144 C1145 C1146 C1147 C1148 C1149 C1151 C1152 C1153 C1154 C1156 C1157 C1158 C1160 C |
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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-0927-2018%22
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