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[Recalled] AXIOM Artis dBC, Model Number 7728392 — A tolerance issue in the power supply of the generator control above a specific… | FDA 2019-06-12

recall fda device united-states

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

ProductAXIOM Artis dBC, Model Number 7728392
Brand / manufacturerSiemens Medical Solutions USA, Inc
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2027-2019
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date12 June 2019

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.

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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