ARTIS icono biplane medical imaging system detector lift malfunction
Siemens is recalling 85 units of the ARTIS icono biplane (Model 11327600) due to potential loss of detector movement capability when adjusted to maximum or minimum lift height limits.
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 of a medical device with a documented mechanical malfunction but no reported injuries or illnesses. The hazard is operational capability loss rather than direct patient harm.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 85 units of the ARTIS icono biplane medical imaging system, Model Number 11327600, distributed nationwide in the US.
The device may lose movement capability in the detector lift mechanism when adjusted to its maximum or minimum height limits. This malfunction could affect the system's operational capability during clinical use.
Users of affected units should contact Siemens Medical Solutions USA, Inc. for guidance on the appropriate corrective action. The affected serial numbers are listed in the recall documentation and should be verified before continued use.
No illnesses or injuries have been reported in association with this issue.
The recalled product
- Product
- ARTIS icono biplane. Model Number: 11327600.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 85
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 (20)
- Model Number: 11327600. UDI-DI: 4056869063317. Serial Numbers: 184246
- 184241
- 184086
- 184178
- 184108
- 184099
- 184070
- 184127
- 184095
- 184167
- 184184
- 184205
- 184199
- 184221
- 184126
- 184047
- 184093
- 184044
- 184096
- 184214
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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