Z-1959-2011

Axiom Aristos FX and FX Plus System

Name: Z-1959-2011 Axiom Aristos FX and FX Plus System
Creator: Siemens Medical Solutions USA, Inc
Published: 2011-02-17
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2011-02-17 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of Axiom Aristos FX and FX Plus System Intended use: Stationary x-ray system on 2011-02-17. The reason FDA records is "During product monitoring, firm discovered a possible hazard to patients when using the detector alpha rotation of all Axiom Aristos FX and FX Plus systems with serial numbers up to and including 1216. When using the...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1959-2011
Status: Terminated
Initiated: 2011-02-17
Posted: 2011-04-12
Terminated: 2013-07-16
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Axiom Aristos FX and FX Plus System Intended use: Stationary x-ray system
Product code: KPR System, X-Ray, Stationary
Reason for recall: During product monitoring, firm discovered a possible hazard to patients when using the detector alpha rotation of all Axiom Aristos FX and FX Plus systems with serial numbers up to and including 1216. When using the detector alpha rotation, the detector may descend unexpectedly during movement or in vertical or table mode. If this occurs in vertical modes, the possibility exists that the detect
FDA root cause: Other
Action: The firm, SIEMENS, sent a "Safety Advisory Notice" dated February 15, 2011 to the affected customers via Update Instructions XP016/10/S on February 17, 2011. The notice described the product, problem and actions to be taken. The customers were instructed to immediately instruct their personnel accordingly; ensure that the safety advisory is placed in the systems's instructions for use; if they have sold this device/equipment and it is no longer in their possession, forward this safety notice to the new owner of the device/equipment; inform SIEMENS about the new owner of the device/equipment, and complete and return the Acknowledgement of receipt form. SIEMENS is preparing a modification of AXIOM Aristos FX and FX Plus that will resolve this potential malfunction. The field modification will be available from February 2011 and is expected to be carried out May 31, 2011. If you have any questions, call 09131-18-9908 or +1-888-826-9702.
Quantity in commerce: 101
Distribution: Nationwide Distribution: USA including states of: AZ, AK, CA, CO, FL, GA. IL, IN, IA, KS, KY, ME, MI, MN, MS, MO, NE, NV, NJ, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, and WI.
Product codes and lots: Model numbers 10093864 and 7414803 -- Serial numbers up to and including 1216.

Product code KPR

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)