Z-1422-2011

Siemens brand ARTISTE MV with Artiste Digital Linear Accelerators in combination with the Flat Panel...

Name: Z-1422-2011 Siemens brand ARTISTE MV with Artiste Digital Linear Accelerators in combination with the Flat Panel...
Creator: Siemens Medical Solutions USA, Inc., Concord, CA
Published: 2010-12-03
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2010-12-03 / Terminated

FDA source

Siemens Medical Solutions USA, Inc., Concord, CA began a recall of Siemens brand ARTISTE MV with Artiste Digital Linear Accelerators in combination with the Flat Panel Positioner; Part No. 8139789; Intended use: To deliver... on 2010-12-03. The reason FDA records is "The firm become aware of a potential issue with ARTISTE system that may result in patient injury should the positioner belt break, and the cam disc (secondary safety mechanism) is not installed and if the flat panel is...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1422-2011
Status: Terminated
Initiated: 2010-12-03
Posted: 2011-02-24
Terminated: 2011-06-30
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens brand ARTISTE MV with Artiste Digital Linear Accelerators in combination with the Flat Panel Positioner; Part No. 8139789; Intended use: To deliver x-ray radiation for therapeutic treatment of cancer. Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Concord, CA; and Siemens Medical Solutions AG, Roentgenstrasse, Kemnath, Germany, and Siemens Medical Solutions AG, Henkestrasse, Erlangen, Germany
Product code: IYE Accelerator, Linear, Medical
Reason for recall: The firm become aware of a potential issue with ARTISTE system that may result in patient injury should the positioner belt break, and the cam disc (secondary safety mechanism) is not installed and if the flat panel is over the patient.
FDA root cause: Other
Action: The firm, Siemens, issued a "Customer Information" letter on December 3, 2010 via mail to all its direct consignees/customers. The letter described the product, problem and actions taken by the firm to the customer. Siemens arranged for an inspection of their customers systems to make sure the safety mechanism is fully functional. Siemens instructed the customers to include the Customer Information letter in their ARTISTE System Owner manual chapter 'Safety Advisory Letters' . If you any questions, please call 925-246-8407.
Quantity in commerce: 20 units
Distribution: Worldwide distribution.
Product codes and lots: Serial No. 5647 - 5718 (Specifically 5647,5651,5652,5660,5657, 5664, 5654,5686,5687,5688,5689, 5606, 5690,5700,5701,5699,5704,5705,5707,5708, 5714, 5716, and 5718)

Product code IYE

K072485Class IIArtiste Mv SaSiemens Medical Solutions USA, Inc. / cleared 2007-12-27

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)