[Recalled] OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 1743574 (w/ Remote Console) The device is intended to be used for x-ray computed tomography and projection x-ray
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 1743574 (w/ Remote Console) The device is intended to be used for x-ray computed tomography and projection x-ray imaging of upper and lower extremities of adult patients and pediatric |
|---|---|
| Brand / manufacturer | Carestream Health, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1207-2019 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 19 March 2019 |
| EAN / barcode | 58008585 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: When the user performs the re-assignment of a parent / companion pair, the parent volume is transferred to the new patient but the companion volume will remain in the original patient s exam.
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 Carestream Health, 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.
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