Class 2 Device Recall Spectral CT on Rails

• Date Initiated by Firm: October 09, 2023
• Date Posted: November 16, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0319-2024
• Recall Event ID: 93362
• 510(K)Number: K212875
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
• Code Information: UDI-DI: 00884838103627; Lot Code: 1005
• Recalling Firm/ Manufacturer: Philips North America; 222 Jacobs St; Cambridge MA 02141-2296
• For Additional Information Contact: Philips Customer Care Solutions Center; 800-722-9377
• Manufacturer Reason for Recall: This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the plan box may not move to the desired needle position. This issue could result in the gantry moving to a location the operator does not expect. If this occurs, it presents a risk that the scan could occur at an incorrect location, or that the unintended motion of the gantry could cause a collision with the user or needle. The other part of the recall involves a software crash when the CCT foot pedal is activated (as described in RES ID93363).
• FDA Determined Cause: Under Investigation by firm
• Action: 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. Remain vigilant and confirm gantry position during procedures. Review the Emergency Stop Procedure and Collision Prevention Guidelines provided in Section 6: Working with Specialized Exams of the IFU. 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).
• Quantity in Commerce: 1 unit
• Distribution: US Nationwide distribution in the state of MN.
• 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 = JAK