Z-1213-2010

Axiom Iconos R200 X-Ray

Name: Z-1213-2010 Axiom Iconos R200 X-Ray
Creator: Siemens Medical Solutions USA, Inc
Published: 2010-01-29
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2010-01-29 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Axiom Iconos R200 X-Ray on 2010-01-29. The reason FDA records is "table can tilt/move when it is not intended". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1213-2010
Status: Terminated
Initiated: 2010-01-29
Posted: 2010-03-27
Terminated: 2010-08-11
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Axiom Iconos R200 X-Ray
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: table can tilt/move when it is not intended
Root cause tag: software
FDA root cause: Software design
Action: The recalling firm has issued a letter to affected customers and will send technicians to apply the fix to each defective device.
Quantity in commerce: 169 units
Distribution: Nationwide Distribution.
Product codes and lots: Model numbers 10093961, 5902767, 5902775, 5902783, 5902791, 5904086, 7152460, and 7152478

Product code JAA

K992660Class IIUrf Digital - OtSiemens Medical Solutions USA, Inc. / cleared 1999-11-05

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)