Z-1270-2012

MOSAIQ System; customers with Siemens branded linear accelerators with a COHERENCE RT Therapist workspace...

Name: Z-1270-2012 MOSAIQ System; customers with Siemens branded linear accelerators with a COHERENCE RT Therapist workspace...
Creator: Siemens Medical Solutions USA, Inc
Published: 2012-02-14
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2012-02-14 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of MOSAIQ System; customers with Siemens branded linear accelerators with a COHERENCE RT Therapist workspace version 2.1a and the 3rd party MOSAIQ Oncology... on 2012-02-14. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1270-2012
Status: Terminated
Initiated: 2012-02-14
Posted: 2012-03-21
Terminated: 2012-09-21
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: 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
Product code: IYE Accelerator, Linear, Medical
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
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 44 affected Siemens Customers
Distribution: 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.
Product codes and lots: MOSIAQ System model number 10568605.

Product code IYE

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)