Z-1343-2022 Class II Terminated

Recalled by Siemens Medical Solutions USA, Inc — Malvern, PA

FDA device recall Z-1343-2022 was initiated by Siemens Medical Solutions USA, Inc on May 24, 2022 and is designated Class II. 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… The recall status is terminated (terminated Jan 22, 2025). Affected quantity: 233 worldwide; 32 US.

Recall Details

Product Type
Devices
Report Date
Jul 13, 2022
Initiation Date
May 24, 2022
Termination Date
Jan 22, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
233 worldwide; 32 US

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.

Distribution Pattern

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.

Code Information

UDI-DI: Artis zeego 04056869010083 Artis Q.zeego 04056869010007

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-1343-2022
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.