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Recall Observatory FDA recall evidence

Device product

AXIOM Artis MP, Model Number 5904466

Z-2014-2019

June 12, 2019

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 83203
Status
Terminated
Classification
Class II
Quantity
24
Official record key
device-enforcement:Z-2014-2019

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: 20334 20052 20303 20238 20242 20322 20282 20363 20338 20295 20348 20172 20264 20367 20258 20265 20250 20249 20281 20243 20339 20321 20294 20254

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.