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Recall Observatory FDA recall evidence

Device product

AXIOM Artis dBC, Model Number 7728392

Z-2027-2019

June 12, 2019

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 83203
Status
Terminated
Classification
Class II
Quantity
53
Official record key
device-enforcement:Z-2027-2019

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: 44125 44151 44101 44246 44185 44262 44263 44199 44105 44084 44080 44072 44243 44198 44171 44275 44215 44255 44081 44242 44265 44189 44289 44145 44060 44144 44184 44286 44223 44068 44193 44244 44201 44251 44229 44304 44152 44136 44254 44277 44279 44268 44206 44278 44259 44260 44168 44267 44110 44218 44165 44271 44135

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.