Device product
AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, and excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or supine positions. The intended use and indications for use of this modified device as described in its labeling have not changed from its predicate device.
Z-1583-2015
Product summary
- Event
- Event 71029
- Status
- Terminated
- Classification
- Class II
- Quantity
- 43
- Official record key
device-enforcement:Z-1583-2015
Official wording
Reason: If the cable cart and the corrugated hose are unable to move freely, the cable holder could drop down and hit patients or system operators.
Code information: Model Number of device: 7414803, Serial #s: 1008 1121 1016 1156 1157 1056 1043 1126 1076 1137 1088 1093 1030 1033 1029 1032 1100 1124 1139 1050 1058 1078 1127 1040 1035 1155 1143 1074 1109 1135 1007 1131 1110 1081 1064 1145 1146 1147 1059 1122 1140 1003 1083
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
If the cable cart and the corrugated hose are unable to move freely, the cable holder could drop down and hit patients or system operators.