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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens SOMATOM Go.Now

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  Class 2 Device Recall Siemens SOMATOM Go.Now see related information
Date Initiated by Firm April 20, 2018
Create Date May 25, 2018
Recall Status1 Terminated 3 on May 23, 2019
Recall Number Z-1939-2018
Recall Event ID 80047
510(K)Number K163296  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product SOMATOM go.Now, Material Number 11061618

There is a potential for a software issue that may cause the need for necessary patient rescans.
Code Information Serial Numbers: 106041,  106051,  106052,  106053,  106054,  106055,  106056,  106057,  106058,  106059,  106060,  106061,  106062,  106065,  106066,  106067,  106068,  106069,  106070,  106071,  106072,  106073,  106074,  106075,  106077,  106078,  106079,  106080,  106081,  106082,  106083,  106084,  106085,  106086,  106087,  106088,  106089,  106090,  106091,  106092,  106093,  106094,  106095,  106096,  106097,  106098,  106099,  106100,  106101,  106102,  106103,  106104,  106105,  106106,  106107,  106108,  106109,  106110,  106111,  106112,  106113,  106114,  106115,  106116,  106117,  106118,  106119,  106120,  106121,  106122,  106123,  106124,  106125,  106126,  106127,  106128,  106129,  106130,  106131,  106132,  106133,  106134,  106135,  106136,  106137,  106138,  106139,  106140,  106141,  106142,  106143,  106144,  106145,  106146,  106147,  106148,  106149,  106150,  106151,  106152,  106153,  106154,  106155,  106156,  106157,  106158,  106159,  106160,  106161,  106162,  106163,  106164,  106165,  106166,  106167,  106168,  106169,  106170,  106171,  106172,  106173,  106174,  106175,  106176,  106177,  106178,  106179,  106180,  106181,  106182,  106183,  106184,  106185,  106186,  106187,  106188,  106189,  106190,  106191,  106192,  106193,  106194,  106195,  106196,  106197,  106198,  106199,  106200,  106201,  106202,  106203,  106204,  106205,  106206,  106207,  106208,  106209,  106210,  106211,  106212,  106213,  106214,  106215,  106216,  106217,  106218,  106219,  106220,  106221,  106222,  106223,  106224,  106225,  106226,  106227,  106228,  106229,  106230,  106231,  106232,  106233,  106234,  106235,  106236,  106237,  106238,  106239,  106240,  106241,  106242,  106243,  106244,  106245,  106246,  106247,  106248,  106249,  106250,  106251,  106252,  106253,  106254,  106255,  106256,  106257,  106258,  106259,  106260,  106261,  106262,  106263,  106264,  106265,  106266,  106267,  106268,  106269,  106270,  106271,  106272,  106273,  106274,  106275,  106276,  106277,  106278,  106279,  106280,  106281,  106282,  106283,  106284,  106285,  106286,  106287,  106288,  106289,  106290,  106291,  106292,  106293,  106294,  106295,  106296,  106297,  106298,  106299,  106300,  106301,  106302,  106303,  106304,  106305,  106306,  106307,  106308,  106309,  106310,  106311,  106312,  106313,  106314,  106315,  106316,  106317,  106318,  106319,  106320,  106321,  106322,  106323,  106324,  106325,  106326,  106327,  106328,  106329,  106330,  106331,  106332,  106333,  106335,  106336,  106337,  106340,  106341,  106342,  106343,  106345,  106347,  106348,  106349,  106350
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Mary Stamer
610-448-6485
Manufacturer Reason
for Recall		 There is a potential for a software issue that may cause the need for necessary patient rescans.
FDA Determined
Cause 2		 Software design
Action The firm, Siemens Healthineers, sent an "Customer Safety Advisory Notices" letter dated 4/20/2018 beginning on 4/20/18 to its customers. The letter described the product, problem and actions to be taken. The letters provided the following information to customers: How can the operator help to avoid a potential risk of the system? To avoid an unnecessary additional X-ray dose to patients please observe the following instructions: Topic 1: If a reconstruction cannot be started after an examination, please reboot the system and repeat the aborted reconstruction. If the error persists, please contact your local Siemens Healthineers service support team. They can help you to decide whether a rescan is necessary or not. Topic 2: If you change the scan parameters kV or mA (tube HV or current), please wait for at least 12 seconds before you trigger a scan command on the control box. If artifacts are visible in the topogram, please repeat the topogram before starting the volume scan. If you have started a volume scan and detect artifacts in the real time display, please stop the scan immediately to avoid an unnecessary X-ray dose. Topic 3: After an osteoporosis scan has been completed, the Osteo reconstruction needs to be started and completed directly after the scan. Therefore the images should be loaded and checked in CT View&Go before the scan/recon tab card is closed. Please do not close the scan/recon tab card before you have reconstructed and checked all Osteo images. A successful and complete Osteo reconstruction is visualized by full green bars in the column Recon Progress of the Job Status table and by images including the Osteo phantom in the tab card CT View&Go (for details please see Fig. 3 below). An example of a correct Osteo reconstruction is provided in Fig. 2. After checking the successful and complete Osteo reconstruction you may close the scan/recon tab card. What has been done to address these issues? What actions shall be t
Quantity in Commerce 4 units in US
Distribution Worldwide Distribution: US (nationwide) including states of: AR, CA, CT, FL, GA, IL, IN, KS, KY, MO, ND, NY, OH, OK, SD, TN, TX, and VA; and countries of: Algeria, Australia, Austria, Bangladesh, Bolivia, Bosnia Herzog., Brazil, Cambodia, Chile, China, Columbia, Costa Rica, Germany, Greece, India, Indonesia, Italy, Japan, Kenya, Kuwait, Lithuania, Mauritius, Morocco, Nepal, Pakistan, Paraguay, Philippines, Poland, Portugal, Republic Korea, Romania, Senegal, Singapore, Slovakia, South Africa, Spain, Switzerland, Thailand, Turkey, Ukraine, and United Kingdom.
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 = JAK and Original Applicant = Siemens Medical Solutions USA, Inc.
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