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Terminated

SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE AG TH, Part No. 5863506, Current R630; Product Usage: The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

FDA Recall Z-1036-2013 · Posted 2013-04-02

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated0013-03-05
Date Terminated2014-08-28
Product Quantity621 units (foreign account) in total

Reason for Recall

Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device.

Firm Action

Siemens Medical Solutions sent a Customer Information letter via mail to all affected customers. The letter identified the affected product, problem and provide instructions on the correction. Customers were instructed to include the Customer Information letter in the Owner Manual chapter "Safety Advisory Letters". 9-16-13 UPDATE: - Control Console SW 9.2.18 was released to support the rol-out 10/18/2013; Distribution of update instructions for TH017/13S and TH018/13S - Distribtuion of the Control Console SW 9.2.18 released

Root Cause

Software design (manufacturing process)

Distribution Pattern

Worldwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123812COHERENCE RT THERAPIST CONNECT WORKSPACE, V2.3, ARIA CONNECTIVITY OPTION FOR SIEMENS NON-IMAGING SYSTEMS, ARIA CONNECTIVSiemens Medical Solutions USA, Inc. · 2013-03-01K092145160MLC OPTIONSiemens Medical Solutions USA, Inc. · 2009-09-18K060226ONCOR EXPRESSIONSiemens Medical Solutions USA, Inc. · 2006-03-15K993425PRIMUSSiemens Medical Solutions USA, Inc. · 1999-11-26

Official Source

View FDA Recall →

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

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