Artis Zee Angiographic x-ray systems.
FDA Recall Z-1309-2014 · Posted 2014-03-31
Advertisement
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIZI
Date Initiated2014-02-07
Date Terminated2015-03-16
Product Quantity9
Reason for Recall
An inappropriate cable connection was assembled for certain Artis zee systems. which may cause a system failure and possibly lead to a restricted maneuverability of the gantry system.
Firm Action
A recall notification letter dated February 7, 2014, was sent to End Users.
Root Cause
Device Design
Distribution Pattern
MN, WI, PA, MI, AL, OH, NC, AR, and NJ.
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.
Advertisement