Z-0095-2009

Syngo Based WS for 3rd party equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1...

Name: Z-0095-2009 Syngo Based WS for 3rd party equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1...
Creator: Siemens Medical Solutions USA, Inc
Published: 2007-11-06
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2007-11-06 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Syngo Based WS for 3rd party equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 7345437 Medical charged-particle... on 2007-11-06. The reason FDA records is "Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail". 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-0095-2009
Status: Terminated
Initiated: 2007-11-06
Posted: 2008-10-16
Terminated: 2010-12-18
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Syngo Based WS for 3rd party equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 7345437 Medical charged-particle radiation therapy system.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail.
Root cause tag: software
FDA root cause: Software design
Action: Service calibration inspection/correction Update instructions TH038/07/S was issued on 11/06/2007 to all customers. The instructions identified the affected products, stated the reason for the update, and listed the steps to update the software. Customer notification was also issued. Software patch planned for release in June 2008.
Quantity in commerce: 1
Distribution: Worldwide Distribution
Product codes and lots: Serial numbers associated with RTT2.0 and RTT2.1

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