Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H.

Abnormal images such as horizontal stripes may be displayed and recovery may not not be possible by restarting the system. The worst case scenario is an operator who is working without a workable image may remove a catheter from the patient's blood vessel and damage the blood vessel.

On 12/21/2021, the firm notified affected customers via a letter titled, "URGENT: MEDICAL DEVICE CORRECTION." The letter indicated, "Corrective Action: When the new parts become available, your Canon service representative will contact you for an appointment to schedule the installation of the modified x-ray flat panel detector and will install on your system. Requests to Customers: Should this problem occur before the modified x-ray flat panel detector is installed on your system, please attempt computer reboot, and contact your Canon service representative. If you have any questions regarding this matter, please contact your Canon service representative. Please share the contents of this letter with all users and reviewing radiologist as well as clinical engineering or biomedical group at your facility. In order to comply with the FDA record keeping requirement, Canon respectfully requests that the attached form be completed and returned. Please fax it to the toll free number at the top of the form, or return via email to [email protected]. Thank you for your urgent attention to this matter." If you have any questions regarding this letter please contact the Regulatory Affairs Manager at 800.421.1968 or your Canon service representative at 800.521.1968.