Z-1769-2008

Medical charged-particle radiation therapy system. Siemens Linear Medical Accelerators equipped with...

Name: Z-1769-2008 Medical charged-particle radiation therapy system. Siemens Linear Medical Accelerators equipped with...
Creator: Siemens Medical Solutions USA, Inc
Published: 2007-10-03
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2007-10-03 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Medical charged-particle radiation therapy system. Siemens Linear Medical Accelerators equipped with COHERENCE Therapist R2.0 and Oncologist R2.0. Product... on 2007-10-03. The reason FDA records is "Software. The firm issued an Advisory Letter Update instruction TH030/07/S as a result of a complaint that images viewed in the device may shift, which could result in mistreatment. The advisory alerts all its affected...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1769-2008
Status: Terminated
Initiated: 2007-10-03
Posted: 2008-08-20
Terminated: 2011-04-29
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Medical charged-particle radiation therapy system. Siemens Linear Medical Accelerators equipped with COHERENCE Therapist R2.0 and Oncologist R2.0. Product update, TH 030//07/S. The COHERENCE Therapist R2.0 software numbers are: 7358299, 7360857, and 8141835 and applies only to those parts used with the following devices: Coherence AG Therapist; Coherence Therapist System; Coherence Impression Therapist; PRIMEVIEW 3i; AG Therapist 3rd party V&R; Coherence Therapist 2.0 and PRIMEVIEW 3i 2.0.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Software. The firm issued an Advisory Letter Update instruction TH030/07/S as a result of a complaint that images viewed in the device may shift, which could result in mistreatment. The advisory alerts all its affected customers of the image issue to prevent potential mistreatment.
Root cause tag: software
FDA root cause: Software design
Action: Customer Safety Advisory Notice was issued on 10/03/2007 to consignees, via certified mail. Consignees are strongly cautioned that they should not further correct the image alignment at this time as doing so will result in incorrect offset values which could lead to incorrect repositioning of the patient. Consignees are instructed to check the "Filter Images on Loading" and "Saving of Filtered Images" config settings, and apply any additional filters to the image BEFORE using the interactive shift or landmark registration tools. Do not correct any perceived issues. A software fix is being validated and will be available soon.
Distribution: Class II Recall - Worldwide Distribution --- including USA and countries of Angola, Australia, Brazil, Canada, Croatia, Denmark, Egypt, France, Germany, Greece, Hungary, India, Iran, Italy, Japan, Malaysia, Netherlands, New Zealand, P.R. China, Poland, Portugal, Republic Korea, Russian, Fed. Saudi Arabia, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Trinidad, Tobago, Turkey, United States, Vietnam.
Product codes and lots: Software Numbers 7358299, 7360857, and 8141835. Applies only to those parts used with the following devices: Coherence AG Therapist-5863506; Coherence Therapist System-7333680; Coherence Impression Therapist-7341410; PRIMEVIEW 3i-7341428; AG Therapist 3rd party V&R-7351898; Coherence Therapist 2.0-8139839 and PRIMEVIEW 3i 2.0-8139847.

Product code IYE

K031764Class IIOncor Avant-Garde with Coherence WorkspacesSiemens Medical Solutions USA, Inc. / cleared 2003-09-05

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)