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Terminated

550 TxT Treatment Table of the Digital Linear Accelerator (LINAC) To deliver X-ray radiation for therapeutic treatment of cancer.

FDA Recall Z-1645-2014 · Posted 2014-05-21

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2014-04-01
Date Terminated2014-12-11
Product Quantity120

Reason for Recall

Table may lose calibration during patient treatment, which may cause the possibility of mistreatment.

Firm Action

Siemens sent an Medical Device Correction, Field Safety Notice of Improvement to End users in March 2014, informing them that a Siemens representative would install a software update. By installation of this software update the issues were solved by the following actions: 1. A plausibility check was introduced for comparing the two independent encoder systems of each table axis. 2. The time between two encoder comparisons was reduced to 50ms and an error code was introduced. Please include this Field Safety Notice in your Digital Linear Accelerator System Owner Manual chapter "Safety Advisory Letters" where it should remain. The relevant National Competent Authority has been informed of this update. We regret any inconvenience that this may cause, and we thank you in advance for your understanding. Further questions please call (610) 219-6300.

Root Cause

Software design

Distribution Pattern

USA ( nationwide) Distribution.

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. · 2003-09-05

Official Source

View FDA Recall →

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

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