Z-1583-2015Class II

AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray system with a flat panel...

Name: Z-1583-2015 AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray system with a flat panel...
Creator: Siemens Medical Solutions USA, Inc
Published: 2015-04-14
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2015-04-14 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of 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... on 2015-04-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1583-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-14
Posted: 2015-05-05
Terminated: 2016-08-17
Recalling firm: Siemens Medical Solutions USA, Inc.
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.
Product code: KPR System, X-Ray, Stationary
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.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Siemens Healthcare, sent a "Safety Advisory Notice" dated April 14, 2015, to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to follow the instructions in the notice; promptly notify and instruct all the staff at your organization making them aware of the problem; and forward this safety information to other organizations that could be affected. If the device has been sold and therefore no longer in your possession, forward the safety notice to the new owner. Additionally, customers were instructed observe this safety notice and comply with the corresponding measures until the update has been fully completed. If you have any questions, contact customer support at 610-219-6300.
Quantity in commerce: 43
Distribution: Nationwide Distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1583-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1583-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-13	2015-05-05

Product code KPR

K013826Class IIAxiom Aristos Fx (Multi Purpose Radiography System)Siemens Medical Systems, Inc. / cleared 2002-02-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)