AArtis Q/ Q.Zen biplane Artis zee biplane Product Usage: Artis 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-0508-2018 · Posted None
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeOWB
Date Initiated2017-08-24
Date Terminated2018-08-29
Product Quantity265 units
Reason for Recall
Within a specific number of Artis zee biplane and Artis Q biplane systems, a connection in the ceiling mount consisting of 12 screws may not have been attached and fastened according to quality standards. A quality inspection will be initiated to ensure all screws in the rotation unit meet quality standards.
Firm Action
Siemens sent an Urgent: Medical Device Correction letter dated August 24, 2017 to all affected customers. The letter identified the affected product, problem and actions to be taken. A local management or dispatch will schedule for an inspection to correct the issue. For questions please call 1-800-888-7436
Root Cause
Employee error
Distribution Pattern
US 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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