FDA recall Z-1940-2018

Siemens Medical Solutions USA, Inc · Class II · device

Product

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

Reason for recall

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

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.

Key facts

Status: Terminated
Initiation date: 2018-04-20
Report date: 2018-06-06
Termination date: 2019-05-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1940-2018