FDA Device recall Z-1583-2015
AXIOM ARISTOS FX
- FDA Device
- Class II
- terminated
- Published 2015-05-13
On 2015-05-13 the FDA classified a Class II recall of AXIOM ARISTOS FX by Siemens Medical Solutions Usa, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1583-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-14 |
| Published | 2015-05-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
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.
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.
Identifiers
| code_info | Model Number of device: 7414803, Serial #s: 1008 1121 1016 1156 1157 1056 1043 1126 1076 1137 1088 1093 1…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1583-2015%22
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