Mevatron KD; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
FDA Recall Z-0790-2012 · Posted 2012-01-17
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2011-12-01
Date Terminated2013-12-02
Product Quantity327 Active Devices - all models
Reason for Recall
Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover.
Firm Action
Siemens sent a Customer Information Letter on December 1, 2011 to all affected customers. The letter idenfied what is the issue, when does the issue occur and what Siemens will do to address the issue. The letter recommend that the Customer Information letter be included in the Linear Accelerator System Owner manual chapter Safety Advisory Letters.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution - USA (nationwide)
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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