PlainRecalls
FDA Devices Moderate Class II Terminated

Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System

Reported: July 13, 2022 Initiated: May 24, 2022 #Z-1343-2022

Product Description

Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System

Reason for Recall

It may occur that after system startup no stand movement is possible any longer in the event of a discharged BIOS battery of the robotic stand control PC. If this problem occurs during startup, all stand movements are blocked and can only be reactivated by a field service engineer.

Details

Units Affected
233 worldwide; 32 US
Distribution
Worldwide distribution - US Nationwide distribution in the states of AL, AR, CA, CO, FL, IL, LA, ME, MN, MO, NC, OH, PA, SC, TN, TX, WI and the countries of Australia, Austria, Azerbaijan, Belgium, Canada, China, Finland, France, Germany, Hong Kong, India, Italy, Japan, Lebanon, Lithuania, Luxembourg, Netherlands, Poland, Portugal, South Korea, Switzerland, United Kingdom.
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 233 worldwide; 32 US.
Why was this product recalled?
It may occur that after system startup no stand movement is possible any longer in the event of a discharged BIOS battery of the robotic stand control PC. If this problem occurs during startup, all stand movements are blocked and can only be reactivated by a field service engineer.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 13, 2022. Severity: Moderate. Recall number: Z-1343-2022.