Artis zee/zeego, Angiographic x-ray system Product Usage: The Artis systems are 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.

This recall has been terminated (originally issued November 17, 2016).

Company: Siemens Medical Solutions Usa, Inc
Recall Initiated: November 1, 2016
Posted: November 17, 2016
Terminated: June 21, 2017
Recall Number: Z-0602-2017
Quantity: 4,657 systems Worldwide
Firm Location: Malvern, PA
Official Source: View on FDA website ↗

Reason for Recall

The possibility exists that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times.

Distribution

US Nationwide Distribution.

Lot / Code Info

Model Numbers: 10094135, 10094137, 10094139, 10094141, 10280959

Root Cause

Software in the Use Environment

Action Taken

Siemens mailed a Customer Safety Advisory Notice to affected customers to inform them of a corrective action they plan to perform to prevent a possible hazard to persons and equipment. The notice identified the associated risks, underlying issues, impact on system operation and actions to be taken.

Reason for Recall

Distribution

Lot / Code Info

Root Cause

Action Taken

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