[Recalled] 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
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| 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 |
|---|---|
| Brand / manufacturer | Siemens Medical Solutions USA, Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1583-2015 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 14 April 2015 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Siemens Medical Solutions USA, Inc
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.