[Recalled] BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306 — Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in i… | FDA 2021-
A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.
Recall details
| Product | BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306 |
|---|---|
| Brand / manufacturer | Philips North America Llc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1774-2021 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 13 April 2021 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury
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 North America Llc
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.