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
FDA Recall Z-1422-2011 · Posted 2011-02-24
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Recalling FirmSiemens Medical Solutions USA, Inc., Concord, CA
Recall StatusTerminated
Product CodeIYE
Date Initiated2010-12-03
Date Terminated2011-06-30
Product Quantity20 units
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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