Recall Z-1495-2021— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1495-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-26

Class II · Ongoing

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2021-03-26. It names one FDA 510(k) clearance: K181407. Product: Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137. Reason: Some Artis zee ceiling systems show an increased abrasion of the cabling at the cable outlet of the inner C-arm, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Ongoing
Initiated: 2021-03-26
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K181407 — Artis zee/zeego & Artis Q/Q.zenSiemens Medical Solution USA, Inc.·cleared 2018-08-15

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 zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137

Reason for recall

Some Artis zee ceiling systems show an increased abrasion of the cabling at the cable outlet of the inner C-arm, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system.

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