ARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
Siemens Medical Solutions is recalling 119 units of the ARTIS icono ceiling (Model 11328100) due to potential loss of movement capability when the detector lift height is adjusted to its maximum or minimum limits.
What this means for you
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: This is an FDA Class II recall involving loss of movement capability in medical device equipment, which poses a risk of harm to users and patients. No reported injuries or deaths are documented in the source text, making it a theoretical risk-of-harm scenario that falls within the High severity category.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the ARTIS icono ceiling, Model Number 11328100, distributed nationwide in the United States. The device has a potential defect that may cause loss of movement capability after the detector lift height is adjusted to its maximum or minimum limits.
A total of 119 units have been recalled. Affected serial numbers range from 194034 to 194227 (specific serial numbers identified in the recall notice). Users should immediately discontinue use of recalled units and contact the manufacturer for repair or replacement instructions.
Healthcare facilities and medical professionals using this equipment should verify the serial number of their device against the provided list. If your ARTIS icono ceiling matches the model number and serial number in this recall, do not adjust the detector lift height to maximum or minimum until the device has been inspected and serviced.
The recalled product
- Product
- ARTIS icono ceiling. Model Number: 11328100.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- loss-of-movement
- equipment-malfunction
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: 11328100. UDI-DI: 4056869295923. Serial Numbers: 194180
- 194184
- 194169
- 194101
- 194131
- 194223
- 194193
- 194216
- 194215
- 194080
- 194186
- 194164
- 194102
- 194054
- 194181
- 194185
- 194194
- 194188
- 194095
- 194094
Distribution
Distributed nationwide across the United States.
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