Z-2097-2008

Radiation therapy system - PRIMEVIEW 3i System equipped with a Coherence Therapist RTT2.1 or Primeview 3i...

Name: Z-2097-2008 Radiation therapy system - PRIMEVIEW 3i System equipped with a Coherence Therapist RTT2.1 or Primeview 3i...
Creator: Siemens Medical Solutions USA, Inc
Published: 2008-05-15
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2008-05-15 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Radiation therapy system - PRIMEVIEW 3i System equipped with a Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 7341428. Medical charged particle... on 2008-05-15. The reason FDA records is "Software - Under certain circumstances, the portal image may be overwritten, which may lead to incorrect dosage". 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-2097-2008
Status: Terminated
Initiated: 2008-05-15
Posted: 2008-09-17
Terminated: 2010-12-20
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Radiation therapy system - PRIMEVIEW 3i System equipped with a Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 7341428. Medical charged particle Radiation therapy system, part of the firm's beam limiting device/accessory. The product provides data processing, and the SYNGO standard medical imaging platform to provide comprehensive oncology workflow solutions for radiation therapy.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Software - Under certain circumstances, the portal image may be overwritten, which may lead to incorrect dosage.
Root cause tag: software
FDA root cause: Software design
Action: An Urgent Medical Device Correction - Customer Safety Advisory Notice letter (TH014/08/S) was released on May 15, 2008. A new software patch is under construction and is planned for release in June 2008. If you have any questions contact Roland Betz at (925) 246-8407.
Distribution: Class II Recall - Product distribution information pending from firm.
Product codes and lots: Medical Linear accelerators equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1 Software Numbers 8146503, 8149119, and 8163318. Applies only to those parts used with the following devices identified in the product descriptions.

Product code IYE

K060226Class IIOncor ExpressionSiemens Medical Solutions USA, Inc. / cleared 2006-03-15

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)