ARTIS icono ceiling. Model Number: 11328100 recallZ-2648-2026 · Siemens Medical Solutions USA, Inc · initiated Jun 8, 2026
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 issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen.
FDA root cause category: Device Design
What the company is doing
Siemens Healthineers notified consignees on about 06/08/2026 via "CUSTOMER SAFETY ADVISORY NOTICE" letter. Consignees were instructed to conduct regular inspections of the gap between the monitor carrier and the ceiling-mounted arm and be attentive to any unusual noises, shaking, wobbling, or other unexpected behavior during system operation, as these may indicate loose screws. If any such signs are observed, limit movements of the DCS and contact Siemens service organization immediately for further instructions. Always ensure that the DCS is positioned for safe use. All affected systems will be corrected by Siemens Healthineers service engineers. Siemens engineers will correct the screwed connection of the monitor ceiling support according to the adapted specifications and instructions. The correction will be released via an Update Instruction AX022/26/S. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented.
Recall details
- Recall number
- Z-2648-2026
- Status
- Open, Classified
- Initiated by the company
- Jun 8, 2026
- Posted by the FDA
- Jul 1, 2026
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 57 units
- Product code
- OWB
- FDA submissions
- K221516
- Distribution
- US Nationwide distribution in the states of CA, GA, IA, IN, LA, MO, NC, NY, PA, SC.
Product description
ARTIS icono ceiling. Model Number: 11328100.
Code information (models, lots, serial numbers)
Model Number: 11328100. UDI-DI: 4056869295923.
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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