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Recall Observatory FDA recall evidence

Device product

Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7728350 & 7728392

Z-0708-2018

June 06, 2017

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 79097
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-0708-2018

Official wording

Reason: Potential for liquid entry

Code information: 10094135, 10094137, 10094141, 10094142, 10094143, 10280959, 10848280, 10848281, 10848282, 10848353, 10848354, 10848355, 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7728350, 7728392

Distribution pattern: U.S. Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for liquid entry