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

PRODUCT
SOMATOM Perspective (Model 10495568)

Recall Number: Z-2474-2018

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