fda_recall · device_recall · high
Siemens Medical Solutions USA, Inc — Class II recall: ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
- Event date
- 2026-06-10 00:00:00Z
- Observed
- 2026-07-09 22:52:20Z
- Source ID
- Z-2205-2026
- Payload hash
- 8fa77079428e0a1a64b14a4a…
Summary
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. Status: Ongoing.
Informational only. Not legal, financial, or medical advice.