Z-0971-2008

Siemens Coherence AG Therapist, Part No: 5863506, medical charged-particle radiation therapy system with...

Name: Z-0971-2008 Siemens Coherence AG Therapist, Part No: 5863506, medical charged-particle radiation therapy system with...
Creator: Siemens Medical Solutions USA, Inc
Published: 2007-10-02
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2007-10-02 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens Coherence AG Therapist, Part No: 5863506, medical charged-particle radiation therapy system with software version 2.1. Siemens AG, Concord, CA on 2007-10-02. The reason FDA records is "Image Orientation Incorrect (Image Shifts) - 1) if the reference image has been calibrated for centering and the reference image is used for patient positioning, the image will shift when the positioning tools are used...". 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-0971-2008
Status: Terminated
Initiated: 2007-10-02
Posted: 2008-04-30
Terminated: 2008-12-24
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens Coherence AG Therapist, Part No: 5863506, medical charged-particle radiation therapy system with software version 2.1. Siemens AG, Concord, CA.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Image Orientation Incorrect (Image Shifts) - 1) if the reference image has been calibrated for centering and the reference image is used for patient positioning, the image will shift when the positioning tools are used. 2) This problem occurs only when non-square reference images are used, such as when images are cropped. At this point, the images will refresh, and the center of the reference im
Root cause tag: software
FDA root cause: Software design
Action: On 10/03/2007, the firm sent Consignees a Customer Safety Advisory Notice informing them of the two potential issues with the display of reference images used for position correction. Consignees will be informed when a solution to this issue has been validated.
Quantity in commerce: 7 units
Distribution: Worldwide Distribution-USA including 48 consignees in the US and 39 outside the US.
Product codes and lots: Serial Numbers: 84601, 84602, 85703, 85714, 85718, 85720, and 00E0815479E1

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)