Z-1795-2013Class II

Axiom Aristos MX Solid State Flat Panel Digital Imager, Model number 5895003. The device is used for...

Name: Z-1795-2013 Axiom Aristos MX Solid State Flat Panel Digital Imager, Model number 5895003. The device is used for...
Creator: Siemens Medical Solutions USA, Inc
Published: 2013-06-05
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2013-06-05 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Axiom Aristos MX Solid State Flat Panel Digital Imager, Model number 5895003. The device is used for diagnostic X-ray imaging on 2013-06-05. FDA classified it as Class II and gives the reason as "Siemens issued a Field Safety Notice about the potential hazard to patients or operators when using the function "table top float" of the AXIOM Aristos MX. When repositioning a patient lying on the table top and...". 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-1795-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-05
Posted: 2013-07-24
Terminated: 2015-02-24
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Axiom Aristos MX Solid State Flat Panel Digital Imager, Model number 5895003. The device is used for diagnostic X-ray imaging.
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: Siemens issued a Field Safety Notice about the potential hazard to patients or operators when using the function "table top float" of the AXIOM Aristos MX. When repositioning a patient lying on the table top and releasing the table top, it is possible that the fingers of the patient or operator are between the table top and the detector tray and if the table top is moved, the fingers can be squee
Root cause tag: design
FDA root cause: Device Design
Action: On 6/5/13, consignees were notified by letter of a "Field Safety Notice" and received instructions about how to avoid the potential risk of this issue while using the device. Siemens also rolled out a modification of AXIOM Aristos MX that will avoid these potential injuries in the future.
Quantity in commerce: 401
Distribution: Nationwide Distribution.
Product codes and lots: Model Number 5895003 with serial numbers 1052 through 2500.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1795-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1795-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-24

Product code MQB

K983732Class IIThorax Fd and Multix FdSiemens Medical Solutions USA, Inc. / cleared 1999-04-21

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)