Class 2 Device Recall Spectral CT on Rails

• Date Initiated by Firm: February 28, 2025
• Date Posted: March 12, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1324-2025
• Recall Event ID: 96423
• 510(K)Number: K212875
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334
• Code Information: Software Version Number 5.1.0; Model number: 728334; UDI-DI: (01)00884838103627(21)1005; Serial Number (SN): 1005
• Recalling Firm/ Manufacturer: Philips Medical Systems Nederland B.V.; Veenpluis 6; Best Netherlands
• For Additional Information Contact: Philips Customer Care Solutions Center; 1-800-722-9377
• Manufacturer Reason for Recall: Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.
• FDA Determined Cause: Under Investigation by firm
• Action: On February 28, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users. " You may continue to use your system(s) in accordance with the intended use and by following the recommendation listed below. " When you see the warning message No communication with table and C-arm. Avoid collisions, Proceed with caution., acknowledge the message by selecting OK and continue using the CT while observing with extra care, collision with the Gantry and C-arm can be avoided. " To protect the patient and the operator from a potential collision due to an automatic gantry motion during scan and plan box not updated during interventional procedure issues, follow the instructions mentioned in the IFU Section 4 Preparing for an Examination and Sub section Gantry Operation: o During all movements of the gantry (automatic and manual), keep the patient under continuous observation. o Take care to avoid pressing the patient against the gantry or between table parts, as well as to avoid disconnecting any infusion or resuscitation apparatus. o For all patient table types, take care when using attachments to avoid collision with the gantry. o Make sure that the patient is strapped securely to avoid dangling of the hands. Ensure that the patient is placed securely on the patient table and is not in danger of falling. o Auto scan means that automatic motions are expected without using the enable button. Ensure the patient table does not collide with the gantry during movement. o During studies, the gantry movements (if applicable) are automatic. Ensure enough clearance between the patient and the gantry. Before initiating the scan, perform manual movements to check the clearance. " To avoid cone beam auto correction artifacts: 1) Reduce the collimation to 32 for brain study, or reduce the collimation to 112 (or any value below 128) for body imaging, which will turn CBAC off. Refer t
• Quantity in Commerce: 1 unit
• Distribution: Domestic: 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