Axiom Artis Systems Operating with VB22, VB23, VB30, and VB31. Model number 5917054, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, and 7728392. Intended use: Angiographic x-ray system.
FDA Recall Z-1312-2010 · Posted 2010-04-08
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIZI
Date Initiated2010-02-16
Date Terminated2012-07-05
Product Quantity640 units
Reason for Recall
Communication problems can occur which may result in unavailability of Bypass Fluoro.
Firm Action
The recalling firm issued a Customer Safety Advisory Notice dated 2/16/10 to inform their customers of the problem. The letter identified the affected product and stated that the problem had been solved by the service technician by the time that customers would receive the letter. The letter also explained when the problem occurred and the possible risks associated with it. In addition, the firm stated what will be done to avoid the problem.
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution
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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