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

Cybersecurity Review

Our cybersecurity experts can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.