AXIOM Artis Systems Product usage: Artis zee is a family of 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-1272-2014 · Posted 2014-03-22
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIZI
Date Initiated2014-02-07
Date Terminated2014-12-30
Product Quantity37
Reason for Recall
Certain units of the AXIOM Artis Systems are using a flat detector cooling unit with inappropriate connectors that may possibly leak, causing a system failure and possible drop out of the gantry system.
Firm Action
Siemens sent a recall notification letter, dated February 7, 2014, to all affected customers. The letter identified the affected product, problem and actions to be taken. For questions call +49 9191 18 0.
Root Cause
Device Design
Distribution Pattern
USA Nationwide Distribution in the states of WI, KY, OH, NJ, NC, FL, PA, MA, IA, TX, NY, IL, MI, AZ, CA, and LA.
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.