Z-0438-06

Arcadis Orbic Mobile X-Ray System

Name: Z-0438-06 Arcadis Orbic Mobile X-Ray System
Creator: Siemens Medical Solutions USA, Inc
Published: 2005-12-12
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2005-12-12 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of Arcadis Orbic Mobile X-Ray System on 2005-12-12. The reason FDA records is "patient information can be stored in another patient's file". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0438-06
Status: Terminated
Initiated: 2005-12-12
Posted: 2006-01-25
Terminated: 2008-09-04
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Arcadis Orbic Mobile X-Ray System
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: patient information can be stored in another patient's file.
FDA root cause: Other
Action: The recalling firm has issued a Customer Safety Advisory to the affected customers per Update Instructions SP030/05/S. The letter informs customers of the potential problem and provides a suggestion to avoid this issue.
Quantity in commerce: 179 units
Distribution: The product was shipped to medical facilities nationwide.
Product codes and lots: model number 8081080

Product code JAK

K042793Class IIArcadis Ordic (Available with Options 3D and 3D Navigation Interface)Siemens Medi Cal Solutions, Inc. / cleared 2004-10-29

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)