Siemens Syngo based WS 3rd Party V&R medical charged-particle radiation therapy system, Part No: 7345437. Siemens AG, Co
FDA device recall Z-0977-2008 · posted 2008-04-30 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- 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
- Action taken
- 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
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 1 unit
- Distribution
- Worldwide Distribution-USA including 48 consignees in the US and 39 outside the US.
- Date initiated
- 2007-10-02
- Date posted
- 2008-04-30
- Date terminated
- 2008-12-24
- Location
- Concord, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ONCOR EXPRESSION (K060226) | Siemens Medical Solutions USA, Inc. | 2006-03-15 |