FDA warns vendor over 'life threatening' risks related to X-ray device

The U.S. Food and Drug Administration has warned X-ray developer Sedecal in writing for failure to address issues with its portable imaging units. 

Issued by the Center for Devices and Radiological Health, the letter refers the company to reports of its self-propelling units' failure to brake, causing them to crash. The agency detailed two specific cases in which the DXD100 mobile radiography units were implicated—one a near-miss involving a patient, the other a crash with an X-ray control panel. 

The FDA letter says Sedecal has not appropriately addressed the documented issues, and that the company has failed to “adequately establish and maintain procedures for validating the device design.” 

What’s more, the agency charges, Sedecal has not appropriately assessed the dangers related to the mobile units, adding that the FDA considers the potential risks to be “life threatening.” 

“Your investigation of the issue concluded that this issue does not pose a risk to safety due to the low speed of the movement and did not consider it as a reportable recall,” the letter reads. "Our assessment concluded that the unintended movement presents a risk to health and your firm’s actions were initiated to reduce the risk to health.” 

The FDA is requiring Sedecal to address the issues and provide detailed documentation of the corrective actions taken. The agency also wants to see a timeline showing target dates for the planned corrections.  

“The specific violations noted in this letter and in the inspectional observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems,” the warning concludes. “Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.”