Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Product Usage: Angiographic x-ray system
FDA Recall Z-1750-2013 · Posted 2013-07-17
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIZI
Date Initiated2013-01-31
Date Terminated2014-11-12
Product Quantity23
Reason for Recall
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.
Firm Action
Siemens sent an Urgent Customer Information letter to their consignees. The letter identified the affected product, problem , update Instructions and actions to be taken. Siemens began to equip affected systems with a modified board assembly in January, 2013.
Root Cause
Device Design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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