ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor recallZ-0956-2023 · Siemens Medical Solutions USA, Inc · initiated Dec 16, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Mechanical connection between the tabletop and table base may be lost.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-0956-2023
- Status
- Open, Classified
- Initiated by the company
- Dec 16, 2022
- Posted by the FDA
- Jan 13, 2023
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 550 units
- Product code
- OWB
- FDA submissions
- K190768, K163286
- 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.
Product description
ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor
Code information (models, lots, serial numbers)
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
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- ARTIS icono biplane 11327600Siemens Healthcare GmbH · System, x-ray, tomography, computed15 recalls2 deaths55 reports
- ARTIS icono floor 11327700Siemens Healthcare GmbH · System, x-ray, tomography, computed15 recalls24 reports
- ARTIS pheno 10849000Siemens Healthcare GmbH · Interventional fluoroscopic x-ray system14 recalls64 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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