Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Siemens YSIO solid state xray imager

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Siemens YSIO solid state xray imagersee related information
Date Initiated by FirmApril 28, 2011
Date PostedJuly 11, 2011
Recall Status1 Terminated 3 on April 10, 2014
Recall NumberZ-2787-2011
Recall Event ID 58897
510(K)NumberK081722 
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
ProductSiemens YSIO - solid state x-ray imager Solid state x-ray imager (flat panel/digital imager), image-intensified fluoroscopic x-ray system
Code Information 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. 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information ContactMeredith Adams
610-448-3237
Manufacturer 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 Determined
Cause 2		Other
ActionSiemens 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 Commerce141
DistributionNationwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MQB
-
-