[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
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | AXIOM Artis dBC, Model Number 7728392 |
|---|---|
| Brand / manufacturer | Siemens Medical Solutions USA, Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2027-2019 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 12 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.