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Recall Observatory FDA recall evidence

Device product

AXIOM Artis TA, Model Number 7007755

Z-2018-2019

June 12, 2019

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 83203
Status
Terminated
Classification
Class II
Quantity
5
Official record key
device-enforcement:Z-2018-2019

Official wording

Reason: A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.

Code information: Serial Numbers: 32090 32085 32091 32094 32095

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.