Recall Z-0956-2023 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor
| Date | Jan 13, 2023 (initiated Dec 16, 2022) |
| Status | Open, Classified |
| Reason | Mechanical connection between the tabletop and table base may be lost. |
| Root cause | Device Design |
| Action | A customer letter dated 12/16/2022 was issued to affected consignees. Consignees are advised the following: -Before treatment is started, check if both transversal guide rails and the roller bearing at the end of each rail are in the correct position. -For the affected OR tables, an inspection including installation of a safety measure will be carried out. Siemens is currently developing this mitigation. Once correction is available, the service department will contact the consignees to arrange a date to perform the corrective action. Consignees are requested to acknowledge the recall letter |
| Quantity | 550 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Armenia, Australia, Austria, Belgium, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Ireland, Italy, Japan, Kazakhstan, Kuwait, Lebanon, Monaco, |
| FDA record | Open on fda.gov |