An independent MR service provider has filed a lawsuit aimed squarely at right-to-repair issues that have long impacted medical equipment industry stakeholders.

The complaint, brought by Marshall Shannon, director of operations at Image Technology Consulting LLC, alleges that restrictions on Philips MR scanner software illegally prevent independent service organizations (ISOs) from installing and servicing the equipment. Original equipment manufacturer (OEM)-imposed software restrictions cannot lawfully prevent access to servicing information and maintenance menus because, the case argues, federal FDA regulations require OEMs to make them available to qualified technicians.

The filing alleges "irreconcilable conflict" between federal obligations and Philips' service-access restrictions. Rather than seek monetary damages, Shannon is asking the court to order Philips to change its policies.
The Service Pack 5 (SP5) software update Philips released almost eight years ago is central to the lawsuit, with Shannon alleging it reclassified service functions into more restrictive access tiers, removed previously available service tools, and tied access to Philips-controlled authorization mechanisms.

A summary of the software update from Philips was previously reviewed by HCB News and included the following passages:

...certain service functions that you may have previously been able to access on older software versions will no longer be available with your service login. […]

All users who need to access the service menus on the device will now need to have a Philips IST (Integrated Security Tool) Smartcard and a valid IST account with appropriate entitlements for the MR system.

A prior case, focused on trade secrets rather than FDA regulations, ruled in favor of Philips
This is not the first legal dispute between Shannon and Philips. In Philips North America, LLC v. Image Technology Consulting, LLC, No. 3:22-CV-147-B, a 2022 lawsuit brought by Philips and concerning tactics Shannon used to circumvent service restrictions, the court ruled overwhelmingly in favor of the OEM.

The legal representatives for Image Technology Consulting cited The Code of Federal Regulations Title 21, Section 820 as part of a motion to dismiss that lawsuit in July of 2022. Those Quality System Regulation requirements mandate that manufacturers "distribute [installation and inspection] instructions and procedures with the device or otherwise make them available to the person(s) installing the device." The motion was denied in part because that case was concerned with the “acquisition, sale, and use of fake and/or unauthorized IST certificates,” which the court determined does not require interpretation of FDA regulations.

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