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
Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Product Usage: Angiographic x-ray system
During the course of product monitoring, Siemens became aware of a tolerance problem in the power supply of the generator control above a specific value, thus, the generator may fail.
These labels are deterministic app interpretations, not FDA categories.
During the course of product monitoring, Siemens became aware of a tolerance problem in the power supply of the generator control above a specific value, thus, the generator may fail.
Code information
Material number 10094137 -- serial numbers 147515, 147500, 147528, 147514, 147516, 147526; material number 10094141 -- serial numbers 154408, 154406, 154453, 154423, 154430, 154425, 154429; material number 10280959 -- serial numbers 160813, 160823, 160812, 160800, 160431, 160814, 160807, 160817, 160816; material number 10094139 -- serial number 157907.
Distribution pattern
United States Nationwide Distribution - including the states of: CA, CO, FL, IA, IL, IN, MA, MD, MI, NC, NY, PA, TX, VA and WA and Puerto Rico.