Recall Z-1646-2022— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1646-2022
Creator: U.S. Food and Drug Administration
Published: 2022-08-10

Class II · Ongoing

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2022-08-10. It names one FDA 510(k) clearance: K220409. Product: Artis pheno- Model No. 10849000. Reason: Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will not be possible to release X-ray any longer until system shutdown..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Ongoing
Initiated: 2022-08-10
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K220409 — ARTIS pheno (VE21) SystemSiemens Medical Solutions USA, Inc.·cleared 2022-06-29

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- Model No. 10849000

Reason for recall

Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will not be possible to release X-ray any longer until system shutdown.

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