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Recall Observatory FDA recall evidence

Device product

SOMATOM Emotion 6 (Model 10165888)

Z-2472-2018

February 01, 2018

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 79665
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2472-2018

Official wording

Reason: A potential risk of unnecessary radiation exposure due to a software issue

Code information: Serial No. 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888

Distribution pattern: Nationwide

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software issue