ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor
FDA device recall Z-0956-2023 · posted 2023-01-13 · Open, Classified
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Mechanical connection between the tabletop and table base may be lost.
- Action taken
- 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 and return the acknowledgement form to Siemens promptly.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- OWB
- Quantity affected
- 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, Gr
- Date initiated
- 2022-12-16
- Date posted
- 2023-01-13
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTIS icono (K190768) | Siemens Medical Solutions USA, Inc. | 2019-09-12 |
| ARTIS pheno (K163286) | Siemens Medical Solution USA, Inc. | 2017-03-09 |