Class 2 Device Recall CIOS ALPHA

• Date Initiated by Firm: March 18, 2019
• Create Date: May 08, 2019
• Recall Status: Terminated on April 16, 2020
• Recall Number: Z-1298-2019
• Recall Event ID: 82621
• 510(K)Number: K132094
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: Cios Alpha, Model Number 10308191 Mobile X-ray system - Product Usage: The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients.
• Code Information: Serial Numbers: 11294 11202 12006 12009 13098 13016 12823 13011 11163 13009 13059 12662 11032 11311 13007 11258 11379 11380 12530 12334 11376 12426 11336 11132 11295 13004 13121 11044 12859 11005 11333 11386 10076 12677 10115 11291 11056 11287 12319 12529 12617 12623 12657 12876 12886 13048 13050 13105 13109 13110 12848 12574 12597 12647 13002 12875 12810 10078 12306 12317 12874 11119 12576 12678 12513 12592 12490 12885 11200 11281 11283 12425 12023 13070 12396 12920 11285 11103 11105 11257 11074 12379 11013 10021 11330 11066 13012 10057 11143 11077 11319 11240 11349 13082 11098 12815 12339 11153 11372 10037 11328 13008 12308 10063 11106 12373 12584 11067 10082 12026 12027 11168 12492 10019 11317 10035 11198 12040 12307 12440 11165 12611 11094 11226 11370 12970 12377 12861 10089 11082 11080 11009 11018 10058 12321 12718 12004 12999 11378 11167 11248 12817 11306 11229 12028 11144 12313 12867 12868 12869 12870 12881 12887 12889 12894 11038 12320 12514 11352 12612 12811 12838 11243 11314 12626 11374 12899 12902 12884 11162 11292 12394 12498 12549 11120 11134 13062 13064 12494 12925 12526 11219 11220 11346 12993 12956 12562 12607 12025 12805 12046 11288 12816 11356 12620 11124 12557 12806 11251 12322 12323 12533 12504 13073 12958 11015 11016 12486 12515 12500 12835 11327 11246 12878 10096 12391 12622 12652 12891 11290 12416 12472 12496 12552 12946 10116 12578 12642 12873 12599 12813 11280 11035 12003 12732 12570 12855 13045 13049 12030 12655 12818 12819 11359 12314 12618 12809 13033 11338 12947 12948 11064 12842 12457 12460 12972 13107
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 40 Liberty Blvd; Malvern PA 19355-1418
• For Additional Information Contact: Anastasia Sokolova; 610-219-4834
• Manufacturer Reason for Recall: Continuous operation at very high tube output may result in increased wear of the radiation emitting components. This may occur when tube voltages of 125 kV are used for a long period, e.g. 30 minutes or more of continuous use. As a result, risk of premature failure of the Monoblock and loss of imaging X-rays.
• FDA Determined Cause: Device Design
• Action: Urgent Medical Device Correction letters dated 3/18/19 were sent to customers.
• Quantity in Commerce: 257
• Distribution: US nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, and WI.
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = OWB and Original Applicant = SIEMENS MEDICAL SOLUTIONS, INC.