FDA recall Z-0119-2023

Siemens Medical Solutions USA, Inc · Class II · device

Product

ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000

Reason for recall

Siemens has become aware of three potential software issues with ARTIS pheno systems with software version VE10B. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system.

Distribution

Domestic distribution nationwide. Foreign distribution worldwide.

Key facts

Status: Ongoing
Initiation date: 2022-09-20
Report date: 2022-11-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0119-2023