Class 2 Device Recall Incisive CT

• Date Initiated by Firm: September 25, 2025
• Date Posted: October 27, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0375-2026
• Recall Event ID: 97699
• 510(K)Number: K180015 K212441 K232491
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X
• Code Information: 1. Product Code (REF): 728143; UDI-DI: 00884838085015; Serial Numbers: 500417, 500404, 500408, 500277, 500037, 500475, 500243, 500028, 500024, 510003, 33022, 500521, 500444, 500305, 500174, 500150, 500029, 500018, 500546, 500472, 510023, 510008, 500532, 500483, 500471, 500446, 500258, 500195, 500568, 33005, 2. Product Code (REF): 728144; UDI-DI: 00884838105508; Serial Numbers: 550375, 550259, 550241, 550195, 550187, 550159, 550116, 550063, 550052, 55400406111940, 550298, 550092, 550188, 5400406113211, 550467, 550328, 550177, 550136, 34318, 550300, 550296, 550248, 550234, 34252, 34224, 34217, 34176, 34157, 34147, 34142, 34108, 550605, 550580, 550129, 550103, 550056, 500509, 34499, 34458, 34405, 34136, 550040, 550447, 550041, 550359, 550350, 34546, 34188, 550686, 550065, 550059, 550025, 500506, 34237, 550474, 550141, 550115, 34401, 552001, 34529, 34408, 34532, 34516, 34280, 34259, 34251, 34223, 34208, 34179, 34174, 34159, 34137, 34082, 34080, 34003
• Recalling Firm/ Manufacturer: PHILIPS MEDICAL SYSTEMS; 222 Jacobs St; Cambridge MA 02141-2289
• For Additional Information Contact: Philips Customer Care Solutions Center; 800-722-9377
• Manufacturer Reason for Recall: Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM (Dose Modulation), the WED (Water Equivalent Diameter) value might set itself to zero, and this may lead to an insufficient dose setting after the surview. If operator misses the insufficient dose and the WED value in User Interface and continues with the subsequent helical/Axial scans, then the obtained images will be noisy due to low dose setting. Issue 3: Due to a software failure, the ECG wave file is not saved. As a result, the cardiac offline image reconstruction fails due to the missing ECG wave file, and the user might rescan the patient. Issue 4: This issue is software fault in which the patient orientation will be changed to NULL under specific random scenarios resulting in radiation being delivered from the wrong orientation (surview scan) or in the wrong position (clinical scan) and will generate incorrect and undiagnosable surview/clinical images. Patients may be rescanned for surview and/or clinical images. Issue 5: During scanning, the preview image display is not consistent, the images are not arriving at a fixed rate, skipping images from time to time during scanning. The obtained images might not support making the clinical diagnosis and the user might decide to re-scan the patient. Issue 6: If a user presses the left and middle/right mouse buttons together or afterwards in a short time, both commands are executed and an incorrect auto ROI is created. This ROI coordinates won t be assigned as the object is empty. As a result, the threshold of contrast level will not be reached in the UI and this will prevent the system from automatically triggering the subsequent clinical scan. There is potential safety risk identified for additionally tracker shots and/or rescan of a patient when the clinical scan is not triggered. This issue only affects the manual ROI process.
• FDA Determined Cause: Under Investigation by firm
• Action: On September 25, 2025, ELECTRONIC PRODUCT RADIATION CORRECTION/URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken. - Follow the instructions within the letter on the use of the systems with updated recommendations. Complete and return the provided response form. Circulate the notice to all users of the device, retain the letter and post it in a visible place likely to be seen/viewed. Actions by recalling firm: 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 the issue (reference FCO72800841). Philips will, without charge bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services. On September 29, 2025 updated ELECTRONIC PRODUCT RADIATIONCORRECTION/URGENT MEDICAL DEVICE CORRECTION letters were sent to customers to notify of incorrect UDI numbers provided in the initial letter.
• Quantity in Commerce: 105 units
• Distribution: Domestic: AL, AR, CA, CT, FL, GA, IL, IN, KY, MD, MI, OH, PA, PR, TN, TX, UT, VA; International: Argentina, Australia, Austria, Brazil, Czeck Republic, Denmark, Ecuador, Finland, France, Germany, Guyana, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Kenya, Latvia, Lebanon, Libya, Netherlands, Nicaragua, Norway, Panama, Philippines, Poland, Portugal, Reunion, Romania, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, U.A.E., Yemen
• 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