The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to save time. A
Summary
The FDA issued a Class II for The INFX-8000F is designed to take advantage of the latest technological innovat by Canon Medical System, USA, INC.. Reason: VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal images. Internal board of the X-ray flat panel detector ma.
Details
Source
Device Recall
External ID
Z-1155-2024
Action Date
2024-02-28
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: UDI-DI: 04987670100208. Serial Number: BGE2292016, BGE2362017
Quantity Affected: 2
Reason for Recall
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.
Distribution
US: CA, LA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-15
Company
Tustin, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 140 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Canon Medical System, USA, INC. has 25 FDA actions in our database, including 25 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Canon Medical System, USA, INC.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Canon Medical System, USA, INC. have FDA actions?
Canon Medical System, USA, INC. has 25 FDA actions in our database, including 25 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1155-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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