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Siemens Medical Solutions USA, Inc recalls SOMATOM Go.Up, Material Number 11061628 There is a potential for a software issue that may cause the need for necessa
Recalled June 6, 2018 · FDA recall Z-1940-2018 · Siemens Medical Solutions USA
Hazard
There is a potential for a software issue that may cause the need for necessary patient rescans. · FDA Class II
Units
33 units in US
Sold at
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.
Description
There is a potential for a software issue that may cause the need for necessary patient rescans.
Product
SOMATOM Go.Up, Material Number 11061628 There is a potential for a software issue that may cause the need for necessary patient rescans.
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →