FDA-Device2025-07-09Class II
interventional fluoroscopic x-ray system
Siemens Medical Solutions USA, Inc
Hazard
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
Sold states
Worldwide.
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
interventional fluoroscopic x-ray system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2021-2025Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief