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Recall Observatory FDA recall evidence

Device product

Artis Zee Angiographic x-ray systems.

Z-1309-2014

February 07, 2014

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 67558
Status
Terminated
Classification
Class II
Quantity
9
Official record key
device-enforcement:Z-1309-2014

Official wording

Reason: An inappropriate cable connection was assembled for certain Artis zee systems. which may cause a system failure and possibly lead to a restricted maneuverability of the gantry system.

Code information: Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959.

Distribution pattern: MN, WI, PA, MI, AL, OH, NC, AR, and NJ.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    An inappropriate cable connection was assembled for certain Artis zee systems. which may cause a system failure and possibly lead to a restricted maneuverability of the gantry system.