Z-1765-2020Class II

System AXIOM Aristos FX Plus - A dedicated x-ray system with a flat panel detector which allows the...

Name: Z-1765-2020 System AXIOM Aristos FX Plus - A dedicated x-ray system with a flat panel detector which allows the...
Creator: Siemens Medical Solutions USA, Inc
Published: 2020-04-06
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2020-04-06 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of System AXIOM Aristos FX Plus - A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of... on 2020-04-06. FDA classified it as Class II and gives the reason as "It was determined that in rare cases persons can receive low dose of unintended radiation. The system performed exposures without the exposure button being pressed. Exposure will be released for less than 500ms...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1765-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-06
Posted: 2020-05-05
Terminated: 2020-10-27
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: System AXIOM Aristos FX Plus - 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; and allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, and extremities. It is not designed for mammography use. Radiographic exposures may be taken with the patient in the sitting, standing, or supine positions.
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: It was determined that in rare cases persons can receive low dose of unintended radiation. The system performed exposures without the exposure button being pressed. Exposure will be released for less than 500ms, therefore, the overall dose is estimated at 0.01mSv or less than 500 mGy in total.
FDA root cause: Radiation Control for Health and Safety Act
Action: Only one user in the United States is affected by this corrective action. The Customer Safety Advisory Notice was sent to the affected customer. Any additional communication regarding this corrective action will include the following statement: The manufacturer will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services, the details of which will be included
Quantity in commerce: 399 (wordwide)
Distribution: Worldwide Distribution
Product codes and lots: serail number 1192

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1765-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1764-2020	Class II	Terminated	FDA Mandated	2020-05-13	2020-05-05
Z-1765-2020	Class II	Terminated	FDA Mandated	2020-05-13	2020-05-05

Product code MQB

K061054Class IIAxiom Aristos Fx PlusSiemens Medical Solutions USA, Inc. / cleared 2006-05-09

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)