Company:Siemens Medical Solutions USA, Inc
Date of Enforcement Report 8/8/2018
Class lI:
PRODUCT
SOMATOM Spirit(Model 10045692 )
Recall Number: Z-2478-2018
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
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