Recall – CT Scanner

Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 8/8/2018
Class II:

PRODUCT
SOMATOM Scope Power (Model 10967888)

Recall Number: Z-2477-2018

REASON
A potential risk of unnecessary radiation exposure due to a software issue.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 2/1/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

DISTRIBUTION
Nationwide

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.