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