—#150896

Product

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.

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K141574
Affected lot / code info: Model Numbers: 10094135, 10094137, 10094139, 10094141, 10280959

Why it was recalled

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

Root cause (FDA determination)

Software in the Use Environment

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: US Nationwide Distribution.

Timeline

Recall initiated: 2016-11-01
Posted by FDA: 2016-11-17
Terminated: 2017-06-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #150896. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.