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Terminated

Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for patient extremities.

FDA Recall Z-1282-2016 · Posted None

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeOWB
Date Initiated2016-03-11
Date Terminated2017-11-17
Product Quantity1 angiography system

Reason for Recall

After importing segmentation results of the left atrium created on the Artis One system, the possibility exists for the results to be mirrored to an electro-anatomical 3D mapping system, CARTO from Biosense Webster Inc.

Firm Action

Siemens mailed an Important Customer Safety Notice to customers to inform them of the issue and the corrective actions they plan to take to address the problem. The letter stated that Siemens service organization will contact customers to arrange a date for the installation of the software update. Customers were instructed to call Siemens service organization for an appointment at 1-800-888-7436.

Root Cause

Software in the Use Environment

Distribution Pattern

Nationwide Distribution to Michigan only

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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