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Terminated

Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system.

FDA Recall Z-2108-2013 · Posted 2013-08-28

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIZI
Date Initiated2013-04-26
Date Terminated2014-11-06
Product Quantity178

Reason for Recall

The firm became aware of a potential issue with Axiom Artis systems installed by a third party installer that may involve incorrect channel nuts being used.

Firm Action

Siemens sent Update Instructions dated December 2012, to all affected customers. This update was initiated on behalf of the US service organization to re-check all systems installed by MEC Group. A call center representative or designated engineer called each site on April 26, 2013, and described the work being done, amount of time needed and number of engineers that would be on site. At that time the call center or engineer scheduled the update with the customer. For further questions please call (610) 219-6300.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Distribution including the states of PA, NJ, DC, VA, MD and DE.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K021021MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTISSiemens Medical Solutions USA, Inc. · 2002-06-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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