The device is an X-ray system that is capable of recall
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…
Why was The device is an X-ray system that is capable of 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: 04987670100192, Serial Number: B1E22X2005
- Product
- 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…
- Recalling firm
- Canon Medical System, USA, INC.
- Quantity
- 1
- Distribution
- US: CA, LA
- Recall date
- February 28, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)