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.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 1
Artis zee,x-ray system, angiographic 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. Procedures that can be performed with the Artis zee include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee systems can also support the acquisition of position triggered imaging for spatial data synthesis
97 distributed worldwide, 12 distributed in United States
App-derived interpretation
Unknownreason.no_named_rule · v1.0.0
Failures can result due to a component defect on Artis zee systems with an A100 Plus generator of a certain delivery lot and 2-focus Megalix Cat Plus tube unit.
These labels are deterministic app interpretations, not FDA categories.
Failures can result due to a component defect on Artis zee systems with an A100 Plus generator of a certain delivery lot and 2-focus Megalix Cat Plus tube unit.
