Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report 6/62018
Class II:

PRODUCT
SOMATOM Go.Up, Material Number 11061628 There is a potential for a software issue that may cause the need for necessary patient rescans. Recall Number: Z-1940-2018

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

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 4/20/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
33 units in US

DISTRIBUTION
Nationwide and Internationally