FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Siemens YSIO - solid state x-ray imager Solid state x-ray imager (flat panel/digital imager), image-intensified fluoroscopic x-ray system
- Recall number
- Z-2787-2011
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Siemens YSIO - solid state x-ray imager Solid state x-ray imager (flat panel/digital imager), image-intensified fluoroscopic x-ray system
- Status
- Terminated
- Initiated
- 2011-04-28
- Posted
- 2011-07-11
- Terminated
- 2014-04-10
- Reason
- There is a potential hazard to staff or patients when lowering the table height on the Ysio system. If staff or patients lower extremities are placed underneath the table and the user lowers the table top, it is possible that parts of the table may collide with extremities and cause injuries.
- Root cause
- Other
- Action
- Siemens sent a Safety Advisory Notice to all affected customers. The Safety Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to place the Safety Notice in the System's instruction for use. If product was distributed further, customers were to forward the safety notice to the new owner and inform the firm of the new owner. Customers were instructed to complete the Acknowledgement of Receipt Form and return to the firm.
- Quantity
- 141
- Distribution
- Nationwide Distribution including Washington, DC and the following States: AR, CA, CO, FL, ID, IL, IN, IA, KS, KY, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI.
- Lot, serial or model codes
- Model numbers 10281013 and 10281163. Serial numbers 30080, 20045, 31072, 31060, 31064, 21065, 31017, 21086, 31040, 30038, 30047, 21088, 30030, 20034, 20112, 21006, 21139, 20093, 20110, 21066, 21031, 20155, 30024, 30055, 21112, 21114, 21122, 31069, 30051, 30076, 31012, 21076, 21077, 31010, 31011, 31018, 31059, 20088, 20089, 20106, 20107, 21052, 31071, 31075, 30032, 31004, 31026, 31108, 21094, 21103, 30078, 20167, 21089, 21098, 21101, 30062, 31019, 31053, 31054, 31077, 31081, 31094, 21085, 30050, 21057, 31093, 31046, 21116, 21117, 21118, 21120, 30021, 31028, 21091, 21123, 21092, 21037, 31001, 30029, 30040, 20149, 21163, 21171, 21172, 21173, 31066, 31067, 30063, 30066, 30067, 31078, 20094, 30052, 21115, 21113, 31003, 20047, 31079, 20193, 31095, 31103, 31104, 31047, 30019, 30023, 30027, 30037, 20118, 21039, 21040, 21108, 31082, 30033, 21100, 30034, 20105, 20115, 20035, 30073, 20185, 21061, 31037, 21095, 21148, 31114, 20184, 21167, 21140, 21175, 21023, 21001, 21004, 21005, 21127, 31096, 31014, 31043, 31045, 21013, 20159, 21160.
- 510(k) numbers
- ["K081722"]
- PMA numbers
- not on file
- Product code
- MQB
- 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