ARTIS icono (ceiling configuration), Fluoroscopic x-ray… recallZ-0523-2024 · Siemens Medical Solutions USA, Inc · initiated Oct 17, 2023
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
Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-existing collisions for up to half an hour when the system is switched off for a longer time (e.g., overnight) and switched on. During this time, system movement is only possible with the "override" function with very slow speed and without further collision protection. This may lead to temporary unavailability of the system for diagnostic and therapeutic usage.
FDA root cause category: Component design/selection
What the company is doing
On October 17, 2023, the firm issued an URGENT MEDICAL DEVICE CORRECTION letter to affected customers. According to the firm's letter, as the unintended behavior is caused by thermal startup effects, its occurrence can be avoided by only switching off the system for a short time. The firm suggests keeping the system running (except during proposed weekly reboot) if availability for treatment of emergency patients is necessary. Please plan for up to half an hour warm-up time after switching on the system. The firm will contact affected customers to modify the mounting of the tube cover to mitigate the probability of occurrence of the issue. You may contact the firm's service organization for an earlier appointment at 1-800-888-7436.
Recall details
- Recall number
- Z-0523-2024
- Status
- Open, Classified
- Initiated by the company
- Oct 17, 2023
- Posted by the FDA
- Dec 9, 2023
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 38 worldwide, 11 US
- Product code
- OWB
- FDA submissions
- K221516
- Distribution
- US Nationwide - Worldwide Distribution: Domestic distribution to FL GA IA IL IN MI MN MO MT PA TX. Foreign distribution to Australia Canada Switzerland China Germany Denmark Egypt Spain Finland United Kingdom Israel Netherlands Sweden South Africa
Product description
ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
Code information (models, lots, serial numbers)
UDI-DI 04056869295923 Serial Numbers: All SN's associated with material number 11328100
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ARTIS icono ceiling 11328100Siemens Healthcare GmbH · System, x-ray, angiographic9 recalls1 report
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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