FDA-Device2023-03-01Class II
Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies. Model Number: 10502200
Siemens Medical Solutions USA, Inc
Hazard
Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values
Sold states
US Nationwide distribution.
Affected count
4 units. Expanded Recall: 93 units
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies. Model Number: 10502200
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1164-2023Don't want to check this manually?
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