Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 4/6/2016
Class lI:
PRODUCT
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.
Recall Number Z-1282-2016
REASON
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.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 3/11/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1 angiography system
DISTRIBUTION
Michigan
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