Recall Z-0119-2023— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0119-2023
Creator: U.S. Food and Drug Administration
Published: 2022-09-20

Class II · Ongoing

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2022-09-20. It names one FDA 510(k) clearance: K163286. Product: ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000. Reason: 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..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Ongoing
Initiated: 2022-09-20
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K163286 — ARTIS phenoSiemens Medical Solution USA, Inc.·cleared 2017-03-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.