Recall Z-0377-2026 ยท JAK System, X-Ray, Tomography, Computed
PHILIPS MEDICAL SYSTEMS
Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X;
| Date | Oct 27, 2025 (initiated Sep 25, 2025) |
| Status | Open, Classified |
| Reason | 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 f |
| Root 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 |
| Quantity | 1 unit (OUS only) |
| 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, |
| FDA record | Open on fda.gov |