PlainRecalls
FDA Devices Moderate Class II Terminated

Artis Q, 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 radio

Reported: November 23, 2016 Initiated: November 1, 2016 #Z-0601-2017

Product Description

Artis Q, 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.

Reason for Recall

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

Details

Units Affected
4,657 systems (worldwide)
Distribution
US Nationwide Distribution.
Location
Malvern, PA

Frequently Asked Questions

What product was recalled? ▼
Artis Q, 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.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 4,657 systems (worldwide).
Why was this product recalled? ▼
The possibility exists that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 23, 2016. Severity: Moderate. Recall number: Z-0601-2017.

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