Philips North America Llc Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy.
Brand
Philips North America Llc
Lot Codes / Batch Numbers
UDI-DI: (01)00884838095168 Serial Numbers
Products Sold
UDI-DI: (01)00884838095168 Serial Numbers; Serial Number 20094 20078 766037 20064 20051 20063 766015 766013 20053 20052 20039 766003 763011 20033 763006 20023 763004 20092 766075 768020 20093 766073 766074 766072 766071 766070 766069 766068 766065 766067 766066 766064 766061 766062 766063 766060 766059 766058 763030 766057 20086 20090 763033 763032 766080 763031 766081 766079 766078 20091 766076 766077 763010 763018 20040 766047
Philips North America Llc is recalling Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed fo due to For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and seco. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen. For radiology users: If the user performed off-set reconstruction on CT devices, after multiple acquisitions, the Relate Position could be inaccurate. This could lead to incorrect diagnosis and treatment.
Recommended Action
Per FDA guidance
Philips issued URGENT Medical Device Correction letter (UMDC) 2023-PD-CTAMI-015) dated 10/9/23. Letter states reason for recall, health risk and action to take: Below are short-term precautions to take until the permanent solution is installed. Enable the Force X/Y to 0/0 option on your device (Refer to the Instructions For Use, Section 3 Preparing for an Exam under Preferences, as well as Section 5 Summary of Scanning Workflows under Scan Workflow). Enabling this option will avoid the issue. After enabling the above referenced option, you may continue to use your system(s) in accordance with the intended use. 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. 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 72800806) to resolve the issue. If you need any further information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026