FDA Devices Moderate Class II Terminated

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

Reported: June 6, 2018 Initiated: April 20, 2018 #Z-1940-2018

Product Description

Reason for Recall

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

Details

Recalling Firm: Siemens Medical Solutions USA, Inc
Units Affected: 33 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.
Location: Malvern, PA

Frequently Asked Questions

What product was recalled? ▼

SOMATOM Go.Up, Material Number 11061628 There is a potential for a software issue that may cause the need for necessary patient rescans.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 33 units in US.

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on June 6, 2018. Severity: Moderate. Recall number: Z-1940-2018.