[Recalled] Brilliance 64:Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes — The firm was notified of a soft
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | Brilliance 64:Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes |
|---|---|
| Brand / manufacturer | Philips Medical Systems (Cleveland) Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1351-2016 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 05 February 2016 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.
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 Philips Medical Systems (Cleveland) 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.