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Recall Observatory FDA recall evidence

Device product

Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system.

Z-2108-2013

April 26, 2013

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 65793
Status
Terminated
Classification
Class II
Quantity
178
Official record key
device-enforcement:Z-2108-2013

Official wording

Reason: The firm became aware of a potential issue with Axiom Artis systems installed by a third party installer that may involve incorrect channel nuts being used.

Code information: Multiple Model numbers: 10281163, 10281013, 10280959, 10272410, 10094200, 10094142, 10094141, 10094139, 10094137, 10094135, 10093961, 10093902, 8890415, 8890407, 8627718, 8395431, 8395415, 8395399, 8395381, 7728392, 7555373, 755365, 7555357, 7412807, 7151066, 7008605, 5904441, 5904433, 5895003, 475525, 475517, 475509.

Distribution pattern: US Distribution including the states of PA, NJ, DC, VA, MD and DE.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The firm became aware of a potential issue with Axiom Artis systems installed by a third party installer that may involve incorrect channel nuts being used.