Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
FDA Recall Z-2404-2015 · Posted 2015-08-18
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeOWB
Date Initiated2015-06-30
Date Terminated2016-12-05
Product Quantity586
Reason for Recall
in case a system error occurs and the system enters the "Bypass Fluoro" mode while the X-ray locking function is active, the only way to exit the X-ray locking function, would be to either resolve the root cause of the system being in "Bypass Fluoro" or to restart the system.
Firm Action
A customer advisory notice, dated June 30, 2015, was sent to consignees informing them of the corrective action that would be performed to prevent the possible loss of the image generation function. Siemens plans to contact end users to install a software patch. For questions regarding this recall call 610-219-6300.
Root Cause
Software design
Distribution Pattern
Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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