Recall Z-1155-2024— Canon Medical System, USA, INC.

Name: FDA recall Z-1155-2024
Creator: U.S. Food and Drug Administration
Published: 2023-11-15

Class II · Ongoing

Class II FDA medical device recall by Canon Medical System, USA, INC., initiated 2023-11-15. It names one FDA 510(k) clearance: K182415. 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 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.. Reason: 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..

Recalling firm: Canon Medical System, USA, INC.
Classification: Class II
Status: Ongoing
Initiated: 2023-11-15
Firm location: Tustin, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K182415 — Alphenix, INFX-8000F/B, V8.0Canon Medical Systems Corporation·cleared 2018-09-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.