FDA Device

Siemens Coherence AG Therapist, Part No: 5863506, medical charged-particle radiation therapy system with software version 2.1. Siemens AG, Concord, CA.

Hazard

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

What You Should Do

Remedy

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.

Products

Siemens Coherence AG Therapist, Part No: 5863506, medical charged-particle radiation therapy system with software version 2.1. Siemens AG, Concord, CA.
Brand
Siemens Medical Solutions USA, Inc
UPC
Serial Numbers: 84601, 84602, 85703, 85714, 85718, 85720, and 00E0815479E1

Units Affected

7 units