Recall Z-1583-2015— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1583-2015
Creator: U.S. Food and Drug Administration
Published: 2015-04-14

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2015-04-14, terminated 2016-08-17. It names one FDA 510(k) clearance: K013826. 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..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2015-04-14
Terminated: 2016-08-17
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K013826 — AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM)Siemens Medical Systems, Inc.·cleared 2002-02-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.