PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: May 5, 2021 Initiated: March 26, 2021 #Z-1495-2021

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.

Details

Units Affected
772 units U.S.
Distribution
Nationwide
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 772 units U.S..
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 5, 2021. Severity: Moderate. Recall number: Z-1495-2021.