FDA Enforcement
Class II
Ongoing
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.
Recall: Z-1154-2024
·
Reported February 28, 2024
Enforcement
- Recall Number
- Z-1154-2024
- Event ID
- 93844
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Canon Medical System, USA, INC.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 28, 2024
- Initiation Date
- November 15, 2023
- Classification Date
- February 16, 2024
- Address
- 2441 Michelle Dr, N/A, Tustin, CA, 92780-7047, United States
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
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.
Code Info
UDI-DI: 04987670100192, Serial Number: B1E22X2005
Distribution
US: CA, LA
Quantity
1