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Recall Observatory FDA recall evidence

Device product

AXIOM Artis dMP, Model Number 7555365

Z-2023-2019

June 12, 2019

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 83203
Status
Terminated
Classification
Class II
Quantity
32
Official record key
device-enforcement:Z-2023-2019

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: 57204 57089 57077 57024 57144 57189 57208 57035 57188 57073 57072 57016 57009 57050 57207 57111 57171 57113 57193 57008 57198 57155 57124 57004 57105 57098 57116 57045 57156 58701 57183 57187

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.