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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens YSIO solid state xray imager

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 Class 2 Recall
Siemens YSIO solid state xray imager
see related information
Date Posted July 11, 2011
Recall Status1 Terminated on April 10, 2014
Recall Number Z-2787-2011
Recall Event ID 58897
Premarket Notification
510(K) Number
K081722 
Product Classification Solid State X-Ray Imager (Flat Panel/Digital Imager) - Product Code MQB
Product Siemens 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, Pennsylvania 19355
For Additional Information Contact Meredith 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/UNDETERMINED: Pending
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MQB and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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