Dallas, TX — Marshall R. Shannon, a U.S. veteran and long-time manufacturer and installer of MRI systems, has issued a formal request for congressional and regulatory oversight into what he calls “a systemic and dangerous misuse of the U.S. legal system” by Philips and other major medical device equipment manufacturers.
Shannon alleges that original equipment manufacturers (OEMs), including Philips, are violating federal regulations outlined in the Federal Food, Drug, and Cosmetic Act (FDCA) and 21 CFR §820.170, which require manufacturers to provide adequate instructions for the safe installation, operation, and maintenance of medical devices.
Despite this legal requirement, Shannon claims OEMs are using private litigation and trade secret claims to deny access to critical installation and servicing instructions. This information, previously accessible until 2019, is now being withheld—an act Shannon says places patients at serious risk.
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“I am currently in litigation for following the law,” says Shannon. “OEMs are using the courts to circumvent FDA regulations and the Library of Congress Medical Device Exemption, while the federal judiciary and agencies stand by.”
Regulatory Breakdown and Judicial Gaps
Shannon is currently involved in Federal Appeal No. 25-10549 (U.S. Court of Appeals for the Fifth Circuit), where he contends that Philips has misrepresented its legal obligations to the courts. Federal judges, he says, have failed to recognize the specific regulatory requirements OEMs must meet under FDA law.
Additionally, Shannon points to the Library of Congress Medical Device Exemption, which permits owners and providers legal access to data files and servicing information for medical devices. According to Shannon, this exemption has been disregarded entirely in his case and many others across the country.
“The FDA’s Division of Industry and Consumer Education has confirmed that my interpretation is correct,” Shannon notes. “Yet OEMs are not being held accountable, and the courts are effectively enabling violations of federal law.”
A Call for Oversight and Reform
In a letter to federal officials, Shannon is calling on:
• The U.S. Congress, particularly the committees overseeing Health and Human
Services (HHS) and the FDA;
• The FDA itself; and
• Regulatory enforcement bodies to investigate and take action against the misuse of private litigation by OEMs.
Shannon also wants answers as to why federal courts are not recognizing the FDCA and Library of Congress exemptions as legal defenses, despite their federal standing.
“These laws were created to ensure that devices like MRI machines are safe and effective. Ignoring them not only breaks the law—it threatens lives.”
Shannon says he has contacted the FDA and federal representatives multiple times over the past 22 years with little to limited response. He believes that without enforcement, the law is meaningless and affects manufacturers, installers, and service providers in nearly every State in this Country.
“This is not just a legal issue—this is a patient safety crisis,” Shannon concludes. “If the law is clear, and the courts won’t enforce it, we need immediate intervention.”
About Marshall R. Shannon:
Marshall Shannon is a veteran, independent medical device manufacturer, and MRI installer based in Texas. With over two decades of experience, he has worked with hospitals and clinics across the World to ensure safe and compliant installation of advanced imaging systems.
