FDA recall Z-1167-2023

Siemens Medical Solutions USA, Inc · Class II · device

Product

Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762471

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-1167-2023