FDA recall Z-2205-2026

Siemens Medical Solutions USA, Inc · Class II · device

Product

ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system

Reason for recall

During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.

Distribution

US and Worldwide

Key facts

Status: Ongoing
Initiation date: 2026-03-09
Report date: 2026-06-10
Voluntary/Mandated: FDA Mandated
Location: Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2205-2026