Siemens Medical Solutions USA, Inc Recall 91361
Description: ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor
Siemens Medical Solutions USA, Inc Recall 91361 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0956-2023 |
| Event ID | 91361 |
| Event Description | ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor |
| Product Type | Devices |
| 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, Netherlands, New Zealand, Norway, Oman, Poland, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, and Vietnam. |
| Quantity | 550 units |
| Recall Reason | Mechanical connection between the tabletop and table base may be lost. |
| Device Classification | 20230125 |
| Device Code Info | 1) ARTIS pheno; Material #10849000; UDI/DI: 4056869046877 2) ARTIS icono biplane; Material #11327600; UDI/DI: 4056869063317 3) ARTIS icono floor; Material #11327700; UDI/DI: 4056869149325 |
| Center Classification Date | 20230113 |
| Recall Initiation Date | 20221216 |
| Recalling Firm | Siemens Medical Solutions USA, Inc |
| Initial Notification | Letter |
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