ARTIS icono ceiling medical imaging monitor suspension system
Siemens Medical Solutions is recalling ARTIS icono ceiling Model 11328100 because screws in the Display ceiling suspension (DCS Fix XL) that hold the monitor may gradually loosen over time, potentially causing the monitor to detach.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a structural/mechanical defect in a medical device mounting system. No injuries or illnesses have been reported; the hazard is mechanical loosening over time. The recall is precautionary in nature, warranting a Moderate severity rating.
Plain-English summary
Siemens Medical Solutions USA, Inc is recalling the ARTIS icono ceiling Model Number 11328100 due to a potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. The concern is that over time, some screws that keep the monitor attached to the suspension may gradually loosen.
57 units of this product have been distributed nationwide across the United States in the states of CA, GA, IA, IN, LA, MO, NC, NY, PA, and SC. Customers who have received this product should contact Siemens Medical Solutions USA, Inc for further guidance on inspection or replacement of the affected suspension component.
The recalled product
- Product
- ARTIS icono ceiling. Model Number: 11328100.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 57
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Number: 11328100. UDI-DI: 4056869295923.
Distribution
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