AXIOM ARISTOS FX — Class II medical device recall Z-1583-2015
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2015-05-13, distributed nationwide. If the cable cart and the corrugated hose are unable to move freely, the cable holder could drop down and hit
| Recall number | Z-1583-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2015-04-14 |
| Classified | 2015-05-05 |
| Reported by FDA | 2015-05-13 |
| Terminated | 2016-08-17 |
| Distributed | Nationwide (US) |
| Quantity | 43 |
| Serial numbers | 1003, 1007, 1008, 1016, 1029, 1030, 1032, 1033, 1035, 1040, 1043, 1050, 1056, 1058, 1059, 1064, 1074, 1076, 1078, 1081, 1083, 1088, 1093, 1100, 1109 and 18 more |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1583-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.