FDA recall Z-2525-2024

Siemens Medical Solutions USA, Inc · Class II · device

Product

Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762472

Reason for recall

The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays

Distribution

US Nationwide distribution.

Key facts

Status: Ongoing
Initiation date: 2024-07-02
Report date: 2024-08-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2525-2024