FDA-Device2018-06-06Class II

SOMATOM go.Now, Material Number 11061618 There is a potential for a software issue that may cause the need for necessary patient rescans.

Siemens Medical Solutions USA, Inc
Hazard

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

Sold states
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.
Affected count
4 units in US
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
SOMATOM go.Now, Material Number 11061618 There is a potential for a software issue that may cause the need for necessary patient rescans.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1939-2018

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