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Terminated

Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959, 10848281, 10848282, 10848283, 10848353, 10848255 Artis zee / zeego and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee / zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee / zeego and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.

FDA Recall Z-2344-2016 · Posted None

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIZI
Date Initiated2016-07-07
Date Terminated2016-12-13
Product Quantity51 units

Reason for Recall

Due to an error in the 19 Live Display, image reproduction may fail in the examination room and the potential exists for the loss of images immediately after system startup.

Firm Action

Siemens sent an Important Customer Safety Notice dated July 7, 2016, by certified mail to customers to inform them of the corrective action they plan to take to prevent potential loss of the image display for live images in the examination room after system startup. Siemens service organization will contact each customer to arrange a date to resolve the issue with a software update of the monitor firmware via AX012/16/S. For questions regarding this recall call 610-448-6461.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide Distribution to AL,AZ,CA,CO,IA,IL,MA,MD,MI,MN,MO,NE,NJ,NY,OH,OR,PA,RI,TX,VA,WA,WI,WV

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123529ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEMSiemens Medical Solutions USA, Inc. · 2013-02-26K073290ARTIS ZEE AND ZEEGOSiemens Medical Solutions USA, Inc. · 2008-02-11

Official Source

View FDA Recall →

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

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