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Recall Observatory FDA recall evidence

Device product

Artis Q systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

Z-2341-2015

June 29, 2015

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 71711
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2341-2015

Official wording

Reason: The possibility exists for a large amount of liquid to seep through the top cover of the table and penetrate the components inside the table. If this occurs, table movements may no longer be possible. No injuries reported.

Code information: Model Number of device: 10848282 10848281 10848355 10848354 serial numbers: 121006 121013 109016 121011 123008 123003 123011 121014 109011 121004 121018 121036 121012 109015 109009 121019 121010 121015 121016 109007 111000 121020 121009 121056 121057 109021 121008 109020 109027 109010 123010 121041

Distribution pattern: US Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The possibility exists for a large amount of liquid to seep through the top cover of the table and penetrate the components inside the table. If this occurs, table movements may no longer be possible. No injuries reported.