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Terminated

Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic Sequenced Cancer Treatment Delivery Option.

FDA Recall Z-2174-2014 · Posted 2014-08-10

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2014-05-28
Date Terminated2015-07-23
Product Quantity160

Reason for Recall

A safety risk exists with automatically sequenced treatment technique using the SIMTEC Auto Field Option where automatic movements of the gantry and the tabletop during an auto-sequenced treatment have the potential to lead to a collision with the patient.

Firm Action

An Urgent Medical Device Correction Field Safety Notice Letter was sent to end users on/about June 2014 which described the product, problem, and actions to be taken to avoid encountering the safety risk to patients and users.

Root Cause

Use error

Distribution Pattern

Nationwide and ROW, including Canada and Mexico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072485ARTISTE MV SASiemens Medical Solutions USA, Inc. · 2007-12-27K031764ONCOR AVANT-GARDE WITH COHERENCE WORKSPACESSiemens Medical Solutions USA, Inc. · 2003-09-05K982502GENESIS IMRT LINEAR ACCELERATORSiemens Medical Solutions USA, Inc. · 1998-07-31K790688MEVATRON 67Siemens Medical Laboratories, Inc. · 1979-04-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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