FDAFDA · Food and drugs·Recall number Z-1155-2024
The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to save time. A revolutionary graphic user interface and a multi-tasking computer enable the system to fully meet the requirement for optimum image quality, safety, ease of use, advanced efficiency and improved workflow. The advanced floormounted system INFX-8000F uses a new flat panel detector to present fluoroscopic and fluorographic images of high quality.
Published February 28, 2024 · Recall initiated: November 15, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal images. Internal board of the X-ray flat panel detector may display abnormal images, such as horizontal stripes, which may lead to the inability to complete an ongoing exam, or the patient may need to be examined with another x-ray system.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Canon Medical System, USA, INC.
- Distributor
- US: CA, LA
- Lot
- UDI-DI: 04987670100208. Serial Number: BGE2292016, BGE2362017
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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