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Recall Observatory FDA recall evidence

Device product

Artis zee floor MN, Model Number 10094142

Z-2032-2019

June 12, 2019

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 83203
Status
Terminated
Classification
Class II
Quantity
23
Official record key
device-enforcement:Z-2032-2019

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: 140212 140115 140101 140205 140213 140204 140209 140219 140224 140218 140221 140220 140206 140223 140105 140226 140108 140102 140109 140100 140202 140214 140114

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.