Spanish x-ray developer Sedecal received a warning letter from the U.S. Food and Drug Administration (FDA) following complaints of its mobile x-ray units “self-propelling” and almost running into a patient in one case.
According to the FDA, the company failed to adequately address “customer complaints reporting DXD100 mobile x-ray units self-propelling [and] crashing into x-ray control panel in one case and almost running into the patient, in the other case. This issue affects all mobile x-ray unit models,” the agency wrote, in a letter posted May 27.
The units involved include the company’s DX-D 100, DX-D 600, and MobileDiagnost wDR systems, the FDA said.
In addition, the FDA noted that the company conducted a recall and risk assessment to address the unintended movement of its MobileDiagnost wDR system. The investigation concluded the issue does not pose a risk to safety due to the low speed of the movement and did not consider it a reportable recall, the FDA said.
“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 agency wrote.
The company should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance, the FDA said.
