[Recalled] Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882446 - Vereos PET/CT — Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could… | FDA 2021-05-01
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882446 - Vereos PET/CT |
|---|---|
| Brand / manufacturer | Philips North America Llc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1988-2021 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 01 May 2021 |
| EAN / barcode | 00884838059559 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious 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.