Recall Z-0956-2023— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0956-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-16

Class II · Ongoing

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2022-12-16. It names 2 FDA 510(k) clearances: K190768, K163286. Product: ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor. Reason: Mechanical connection between the tabletop and table base may be lost..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Ongoing
Initiated: 2022-12-16
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

2 on FDA's record

K190768 — ARTIS iconoSiemens Medical Solutions USA, Inc.·cleared 2019-09-12
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, ARTIS icono biplane, and ARTIS icono floor

Reason for recall

Mechanical connection between the tabletop and table base may be lost.

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