Recall Z-1154-2024— Canon Medical System, USA, INC.

Name: FDA recall Z-1154-2024
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: K210900. 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 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.. 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

K210900 — Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2Canon Medical Systems Corporation·cleared 2021-04-12

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 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.

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.