Z-2787-2011

Siemens YSIO - solid state x-ray imager Solid state x-ray imager (flat panel/digital imager)...

Name: Z-2787-2011 Siemens YSIO - solid state x-ray imager Solid state x-ray imager (flat panel/digital imager)...
Creator: Siemens Medical Solutions USA, Inc
Published: 2011-04-28
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2011-04-28 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens YSIO - solid state x-ray imager Solid state x-ray imager (flat panel/digital imager), image-intensified fluoroscopic x-ray system on 2011-04-28. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2787-2011
Status: Terminated
Initiated: 2011-04-28
Posted: 2011-07-11
Terminated: 2014-04-10
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
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: 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.
FDA 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 in commerce: 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.
Product codes and lots: 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.

Product code MQB

K081722Class IIYsioSiemens Medical Solutions USA, Inc. / cleared 2008-08-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)