FDA recall Z-1165-2023

Siemens Medical Solutions USA, Inc · Class II · device

Product

Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10762472

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

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2022-12-21
Report date
2023-03-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1165-2023