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Terminated

MOSAIQ System; customers with Siemens branded linear accelerators with a COHERENCE RT Therapist workspace version 2.1a and the 3rd party MOSAIQ Oncology Information System. MOSAIQ Oncology information system is owned and marketed by IMPAC Medical System, Inc. MOSAIQ is distributed by Siemens Medical Solutions USA, Inc, Radiation Oncology under a distributor contract with IMPAC Medical. Distributed by Siemens Healthcare, Concord, Ca. Product Usage: Medical charged particle radiation therapy system. The intended use of the SIEMENS branded PRIMUS, ONCOR and ARTISTE Solution family of linear accelerators systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. P

FDA Recall Z-1270-2012 · Posted 2012-03-21

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2012-02-14
Date Terminated2012-09-21
Product Quantity44 affected Siemens Customers

Reason for Recall

Images used in treatment planning may belong to another patient. Risk of treatment to wrong area. Software update to upgrade Siemens installed base to the latest release of MOSAIQ version 2.00X3 SP5, for RT Therapist version 2.1A

Firm Action

Siemens sent a Customer Information letters to all affected customers. The Customer information letters inform customers of the release of MOSAIQ 2.00X3 SP5 which specifically addresses a safety issue that is only found when MOSAIQ is used with COHERENCE Therapist 2.1 MQ (also called RTT2.1A). This letter is to be kept with Customer information documentation. Update Instruction TH004/12S are being issued with the update. The Software update is delivered and installed by qualified Field Service Engineers. For questions, contact your responsible SIEMENS Service Engineer or Application Specialist.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - USA (nationwide) including the states of KY, PA, TN, WI, and P.R. and the countries of Australia, Belgium, Bosnia Herzeg. China, Colombia, Croatia, Czech Republic, Germany, India, Ireland, Japan, Lebanon, Malaysia, Mexico, New Zealand, Philippines, Poland, Russian Federation, South Africa, Saudi Arabia, Thailand, Turkey, and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K090683SYNGO RT THERAPIST CONNECTSiemens Medical Solutions USA, Inc. · 2009-05-08K981313SEQUENCERImpac Medical Systems, Inc. · 1998-07-09

Official Source

View FDA Recall →

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

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