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[Recalled] Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor, Model No. 10848353 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnosti

recall fda device united-states

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

ProductArtis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor, Model No. 10848353 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to,
Brand / manufacturerSiemens Medical Solutions USA, Inc
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-1496-2020
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date14 February 2020
EAN / barcode10848355

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: A software issue could potentially cause the stand and table movements to be blocked.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Siemens Medical Solutions USA, Inc

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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