Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
This recall is currently active, issued November 15, 2023. It was issued by Philips North America.
- Company
- Philips North America
- Recall Initiated
- October 9, 2023
- Posted
- November 15, 2023
- Recall Number
- Z-0306-2024
- Quantity
- 1 unit
- Firm Location
- Cambridge, MA
- Official Source
- View on FDA website ↗
Reason for Recall
When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would result in the system needing to be restarted.
Distribution
US Nationwide distribution in the state of MN.
Lot / Code Info
UDI-DI: 00884838103627; Lot Code: 1005
Root Cause
Under Investigation by firm
Action Taken
An URGENT Medical Device Correction notification letter dated 10/9/23 was sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users. Below are short-term precautions to take until the permanent solution is installed. Leave the audible preparation indication alert turned on, set as default in the factory settings, and wait for the audible alert before pressing the foot pedal. If you have disabled the audible alert, you can turn it back on by following instructions provided in Section 4: Preparing for an Examination of the IFU. Wait for the blue arrow to appear on the screen on the console and in the procedure room, prior to depressing the fluoroscopy pedal. 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 software update (FCO 72800805) to resolve the issue. 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 the Customer Care Solutions Center (1-800-722-9377).