Z-0118-06

Arcadis Varic Mobile X-Ray System

Name: Z-0118-06 Arcadis Varic Mobile X-Ray System
Creator: Siemens Medical Solutions USA, Inc
Published: 2005-08-01
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2005-08-01 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of Arcadis Varic Mobile X-Ray System on 2005-08-01. The reason FDA records is "Screws may become loose and fall into the OR field during surgery". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0118-06
Status: Terminated
Initiated: 2005-08-01
Posted: 2005-11-02
Terminated: 2006-07-19
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Arcadis Varic Mobile X-Ray System
Product code: IZL System, X-Ray, Mobile
Reason for recall: Screws may become loose and fall into the OR field during surgery.
FDA root cause: Other
Action: The recalling firm has their Service Engineers visiting each site to check the screws on the window and secure them with Loctite per Update Instructions SP022/05/S. The Service Engineer is also informing the account of the problem during the visits.
Quantity in commerce: 24 units
Distribution: The products were shipped nationwide to a distributor, a physician, and medical facilities
Product codes and lots: Model number 8080017

Product code IZL

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)