openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
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device · product 1 of 1
ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 - Product Usage:AXIOM 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. Procedures that can be performed with the AXIOM Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Axiom Artis can also support the acquisition of position triggered imaging for spatial data synthesis.
Potential exists for one or more axes of the robotic stand to become blocked by their safety brakes; In the event the axis is blocked by its safety brake, the robotic stand can no longer perform the intended movements
These labels are deterministic app interpretations, not FDA categories.
Potential exists for one or more axes of the robotic stand to become blocked by their safety brakes; In the event the axis is blocked by its safety brake, the robotic stand can no longer perform the intended movements
