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Recall Observatory FDA recall evidence

Device product

SOMATOM go.Now; Models #11061610 & 11061618 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data

Z-2399-2019

July 31, 2019

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 83556
Status
Terminated
Classification
Class II
Quantity
0
Official record key
device-enforcement:Z-2399-2019

Official wording

Reason: The injector holder could potentially fall off together with the injector and the storage box.

Code information: All serial numbers

Distribution pattern: US Nationwide Distribution in the states FL KS WI NE MS OH TX NY LA IN IL OK MI GA NJ AK CT AL MD

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The injector holder could potentially fall off together with the injector and the storage box.