—#66981

Product

Siemens Primeview 3i medical charged-particle radiation therapy system, Part No: 7341428, with software version 3i. Siemens AG, Concord, CA.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K060226
Affected lot / code info: Serial Numbers: 102301, 104201, 00E0815462E6, 5602, 48701, 57401

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 4040 Nelson Ave, Concord, California 94520-1200

Distribution

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

Timeline

Recall initiated: 2007-10-02
Posted by FDA: 2008-04-30
Terminated: 2008-12-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #66981. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.