Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333

Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operators foot. If foot or leg entrapment occurs while pressing Unload Pedal, the risk to operators may include: pain, muscle or ligament sprain, abrasion, laceration, contusion, fracture, loss of function, and joint dislocation.

An URGENT Medical Device Correction notification letter dated 3/17/23 was sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users Immediately stop using the Unload Pedal of the Foot Switch until Philips installs a solution on your system. Instead of using the Unload Pedal, please use the Unload Patient function on the Gantry Control Panels, or use other Table In/Out, Up/Down functions on the Gantry Control Panels, CT Scan Control Box, or Hardware Interventional Controls to fulfill the normal patient unloading function, as instructed in the IFU. You may continue to use Load Pedal, and Free-Float Pedal of Foot Switch, as they are not affected by this Urgent Medical Device Correction Letter. Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction Letter, understanding of the issue, and required actions to be taken. Circulate this Urgent Medical Device Correction Letter to all users of this device so that they are aware of the issue. Please retain this letter with your system(s) until a solution is installed on your system; ensure the letter is in a place likely to be seen/viewed. Actions planned by Philips to correct the problem Philips will contact you to schedule a time for a Philips Field Service Engineer (FSE) to visit your site and install the solution to resolve this issue (refer to FCO72800795). Please be assured that maintaining a high level of safety and quality is our highest priority. If you need any further information or support concerning this issue, please contact your local Philips representative: For North America, contact the Customer Care Solutions Center (1-800-722-9377).