Siemens Medical Solutions USA, Inc Siemens Coherence AG Therapist, Part No: 5863506, medical charged-particle radiation therapy system with software version 2.1. Siemens AG, Concord, CA. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Lot Codes / Batch Numbers
Serial Numbers: 84601, 84602, 85703, 85714, 85718, 85720, and 00E0815479E1
Products Sold
Serial Numbers: 84601, 84602, 85703, 85714, 85718, 85720, and 00E0815479E1
Siemens Medical Solutions USA, Inc is recalling Siemens Coherence AG Therapist, Part No: 5863506, medical charged-particle radiation therapy system due to Image Orientation Incorrect (Image Shifts) - 1) if the reference image has been calibrated for centering and the reference image is used for patient p. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026