—#164276

Product

SOMATOM Go.Up, Material Number 11061628 There is a potential for a software issue that may cause the need for necessary patient rescans.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K163296
Affected lot / code info: Serial Numbers: 108052, 108053, 108054, 108055, 108056, 108057, 108058, 108059, 108060, 108061, 108062, 108063, 108064, 108065, 108066, 108067, 108068, 108069, 108070, 108071, 108072, 108073, 108074, 108075, 108076, 108077, 108078, 108079, 108080, 108081, 108082, 108083, 108084, 108085, 108086, 108087, 108088, 108089, 108090, 108091, 108092, 108093, 108094, 108095, 108096, 108097, 108098, 108099, 108100, 108101, 108102, 108103, 108104, 108105, 108106, 108107, 108108, 108109, 108110, 108111, 108112, 108113, 108114, 108115, 108116, 108117, 108118, 108119, 108120, 108121, 108122, 108123, 108124, 108125, 108126, 108127, 108128, 108129, 108130, 108131, 108132, 108133, 108134, 108135, 108136, 108137, 108138, 108139, 108140, 108141, 108142, 108143, 108145

Why it was recalled

There is a potential for a software issue that may cause the need for necessary patient rescans.

Root cause (FDA determination)

Software design

Action the firm took

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

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2018-04-20
Terminated: 2019-05-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #164276. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.