The Recall Desk

FDA (Devices) recall action 93844

Canon Medical System, USA, INC. recalled 2 products on 2024-02-28

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2024-02-28
Critical
0
Units
3

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2024-02-28

    X-Ray C-Arm System Internal Board Defect Causes Abnormal Images

    Canon Medical System X-ray C-arm systems may display abnormal images due to an internal board manufacturing defect, potentially preventing exam completion and requiring patients to be re-examined with alternative equipment.

    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 proce
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2024-02-28

    X-ray fluoroscopy system may display abnormal images due to detector board defect

    Canon Medical's INFX-8000F X-ray system may display abnormal horizontal stripe patterns due to a manufacturing change in the flat panel detector's internal board, potentially preventing exam completion.

    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
    Category
    Distribution
    2 states