The INFX-8000F is designed to take advantage of the recall
The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to save time. A revolutionary graphic user…
Why was The INFX-8000F is designed to take advantage of the recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 04987670100208. Serial Number: BGE2292016, BGE2362017
- Product
- The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to save time. A revolutionary graphic user…
- Recalling firm
- Canon Medical System, USA, INC.
- Quantity
- 2
- Distribution
- US: CA, LA
- Recall date
- February 28, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)