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Terminated

Siemens Primeview 3i 2.1 medical charged-particle radiation therapy system, Part No: 8147675, with software version 3i. Siemens AG, Concord, CA.

FDA Recall Z-0981-2008 · Posted 2008-04-30

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2007-10-02
Date Terminated2008-12-24
Product Quantity3 units

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

Firm 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.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution-USA including 48 consignees in the US and 39 outside the US.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060226ONCOR EXPRESSIONSiemens Medical Solutions USA, Inc. · 2006-03-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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