Recall Z-1294-2022— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1294-2022
Creator: U.S. Food and Drug Administration
Published: 2022-06-10

Class II · Ongoing

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2022-06-10. It names one FDA 510(k) clearance: K201156. Product: Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000. Reason: A video signal from one of the transceivers of the Large Display may be lost. In very rare cases, both transceivers of the Large Display could potentially fail which can lead to the loss of both video signals. This issue can sporadically affect the Large Display in the examination room as well as the displays in the control room..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Ongoing
Initiated: 2022-06-10
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K201156 — ARTIS pheno (VE2)Siemens Medical Solution USA, Inc.·cleared 2020-06-29

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, Interventional Fluoroscopic X-Ray System, Model No. 10849000

Reason for recall

A video signal from one of the transceivers of the Large Display may be lost. In very rare cases, both transceivers of the Large Display could potentially fail which can lead to the loss of both video signals. This issue can sporadically affect the Large Display in the examination room as well as the displays in the control room.

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