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Siemens Medical Solutions USA, Inc recalls AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray system with a flat panel detector which al
Recalled May 13, 2015 · FDA recall Z-1583-2015 · Siemens Medical Solutions USA
Hazard
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. · FDA Class II
Units
43
Sold at
Nationwide Distribution.
Description
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.
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.
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →