FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Siemens Primeview 3i medical charged-particle radiation therapy system, Part No: 7341428, with software version 3i. Siemens AG, Concord, CA.
- Recall number
- Z-0974-2008
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Siemens Primeview 3i medical charged-particle radiation therapy system, Part No: 7341428, with software version 3i. Siemens AG, Concord, CA.
- Status
- Terminated
- Initiated
- 2007-10-02
- Posted
- 2008-04-30
- Terminated
- 2008-12-24
- Reason
- 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
- 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
- 6 units
- Distribution
- Worldwide Distribution-USA including 48 consignees in the US and 39 outside the US.
- Lot, serial or model codes
- Serial Numbers: 102301, 104201, 00E0815462E6, 5602, 48701, 57401
- 510(k) numbers
- ["K060226"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 2937457
- Firm city
- Concord
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28