Class 2 Device Recall Alphenix, INFX8000C/B, INFX8000C/S, V9.2

• Date Initiated by Firm: November 15, 2023
• Date Posted: February 16, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1154-2024
• Recall Event ID: 93844
• 510(K)Number: K210900
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• 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.
• Code Information: UDI-DI: 04987670100192, Serial Number: B1E22X2005
• Recalling Firm/ Manufacturer: Canon Medical System, USA, INC.; 2441 Michelle Dr; Tustin CA 92780-7047
• For Additional Information Contact: 714-730-5000
• Manufacturer 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.
• FDA Determined Cause: Component change control
• Action: On 11/15/23 correction notices were distributed to customers who were asked to do the following: 1) Should this issue occur please attempt to restart the system and contact your service representative. 2) A recalling firm representative will contact you to schedule a time to replace the flat panel detector on the console. The parts required to address the defect are expected to be available no earlier that December 2023. 3) Complete and return the customer reply form via email to RAFFAIRS@US.MEDICAL.CANON For questions, please contact our InTouch team at intouchdispatch@us.medical.canon or 800-421-1968, or 800.521.1968.
• Quantity in Commerce: 1
• Distribution: US: CA, LA
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OWB