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FDA (Device enforcement)Recalled 2022-05-24closedclass ii

Siemens Medical Solutions USA, Inc: Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System

Is my product affected?

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

  • UPC 04056869010083
  • UPC 04056869010007

Check against the official notice below — it lists the full affected range.

What happened

Siemens Medical Solutions USA, Inc. is recalling Artis zeego and Artis Q.zeego interventional fluoroscopic x-ray systems due to a hazard affecting the robotic stand control computer. If the BIOS battery in the robotic stand control PC becomes discharged, the system may experience complete loss of stand movement capability after startup. When this occurs, all stand movements become blocked and cannot be restored without assistance from a field service engineer.

The recall affects 233 systems worldwide, including 32 units in the United States distributed across Alabama, Arkansas, California, Colorado, Florida, Illinois, Louisiana, Maine, Minnesota, Missouri, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, and Wisconsin, as well as systems distributed internationally to multiple countries. The source document does not specify a remedy or action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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 from the source

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. 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. Quantity: 233 worldwide; 32 US Lot/code info: UDI-DI: Artis zeego 04056869010083 Artis Q.zeego 04056869010007

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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