FDAFDA · Food and drugs·Recall number Z-1154-2024
The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and processing software, and a patient radiographic table.
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: 04987670100192, Serial Number: B1E22X2005
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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