PlainRecalls
FDA Devices Moderate Class II Ongoing

Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies. Model Number: 10502200

Reported: March 1, 2023 Initiated: December 21, 2022 #Z-1164-2023

Product Description

Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies. Model Number: 10502200

Reason for Recall

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

Details

Units Affected
4 units. Expanded Recall: 93 units
Distribution
US Nationwide distribution.
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies. Model Number: 10502200. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 4 units. Expanded Recall: 93 units.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on March 1, 2023. Severity: Moderate. Recall number: Z-1164-2023.