FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: YSIO X.Pree
- Recall number
- Z-0730-2022
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- YSIO X.Pree
- Status
- Open, Classified
- Initiated
- 2022-03-07
- Posted
- not on file
- Terminated
- not on file
- Reason
- For the automated multi-image-acquisition procedure Ortho x-ray collimation is set in a preparative stage for the entire examination area prior to the exam. During acquisition of each individual x-ray image, the x-ray collimator is automatically positioned in a way that the subsequent series of acquisition covers the defined field of view needed for each step. However, during the acquisition the collimation area displayed to the operator on the User Interface does not correctly represent the collimation area specified by the system. It indicates to the user an open collimator instead, e.g., the information displayed on the User Interface shows wider area of collimation than values preset prior to the examination. However, the collimation of the x-ray is performed correctly and always matches the examination area predefined by the user.
- Root cause
- Software design
- Action
- Siemens Medical Solutions USA, Inc. has initiated a Customer Advisory Notice to all affected customers. The letter inform customers that the firm will distribute a software correction via update instruction at no cost to the customers.
- Quantity
- 53 units
- Distribution
- US Nationwide, Worldwide distribution
- Lot, serial or model codes
- 11107464
- 510(k) numbers
- ["K201670"]
- PMA numbers
- not on file
- Product code
- KPR
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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