ARTIS icono floor Medical Imaging System Detector Movement Loss Recall
Siemens Medical Solutions is recalling 30 units of the ARTIS icono floor (Model 11327700) due to potential loss of detector movement capability when adjusted to maximum or minimum 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves an FDA Class II medical device where a loss of operational capability could impair clinical functionality and patient care delivery. Although no injuries or illnesses are reported in the source text, the potential for loss of critical device movement capability in medical imaging equipment presents a risk of harm.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 30 units of the ARTIS icono floor medical imaging system, Model Number 11327700 (UDI-DI: 4056869149325), nationwide in the United States. The device may experience loss of movement capability in the detector lift mechanism after the detector is adjusted to its maximum or minimum height limits.
This condition could affect the device's operational functionality. Affected units bear specific serial numbers ranging from 174132 to 174067, as detailed in the device identification.
If you operate or maintain an affected ARTIS icono floor system, contact Siemens Medical Solutions USA, Inc. for guidance on inspection, repair, or replacement of the affected equipment.
The recalled product
- Product
- ARTIS icono floor. Model Number: 11327700.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 30
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: 11327700. UDI-DI: 4056869149325. Serial Numbers: 174132
- 174128
- 174085
- 174152
- 174056
- 174055
- 174083
- 174121
- 174122
- 174087
- 174044
- 174061
- 174099
- 174058
- 174063
- 174150
- 174126
- 174125
- 174096
- 174145
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
Same manufacturer · Siemens Medical Solutions USA, Inc
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