Philips North America Llc has recalled 12 units of the Oncology Essentials Package used with Spectral CT imaging systems. The recall was initiated because the oncology marking laser from a third-party system can reflect off the gantry cover surface of the CT scanner. This reflection can lead to incorrect marking of treatment areas, potentially resulting in misdiagnosis and subsequent incorrect medical treatment. Affected units were distributed in several U.S. states including Arizona, Hawaii, Minnesota, Vermont, and West Virginia.
A laser beam used for patient alignment can bounce off the smooth surface of the CT scanner cover, creating a secondary or misplaced laser mark on the patient. This can cause medical professionals to target the wrong area during radiation therapy or surgery, leading to serious health complications from incorrect treatment.
Manufacturer notification and technical guidance
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.