[Recalled] Brilliance 40, Model 728235 Product Usage: 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. T
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | Brilliance 40, Model 728235 Product Usage: 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. These devices may include signal analysts and display equipment, patient |
|---|---|
| Brand / manufacturer | Philips Medical Systems (Cleveland) Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0544-2019 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 18 October 2018 |
| EAN / barcode | 62985063 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
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 →
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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.