[Recalled] Ingenuity Core 128, (Code 728323) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. — Philips has identified that certain fasteners cann
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | Ingenuity Core 128, (Code 728323) Intended to produce images of the head and 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-0391-2018 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 10 November 2017 |
| EAN / barcode | 00884838059474 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm.
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.