The FDA recently issued a warning via letter to Hitachi Medical Systems America Inc. relating to the company's failure to properly file reports to the agency regarding patient complaints and device malfunctions.
The complaints included injuries such as burns and hearing loss while patients were scanned by the company's magnetic resonance imaging (MRI) systems. There were also a few occurrences of MRI malfunctions that did not lead to patient injuries. Each of the complaints took place between 2002 and 2004.
The letter, issued to Hitachi's Twinsburg, Ohio-based unit on July 13 but posted to the FDA website last week, emphasized to the company that the problems "may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems."
In a statement, Sheldon Schaffer, VP, GM, of Hitachi Medical Systems' MRI business, said that the company has resolved many of the FDA's concerns and is currently working on solutions to the rest.
Most companies that are issued such warnings settle the problems themselves and the FDA is not often forced to take action. However, failure to respond can lead to fines, seizing products, and can impact a company's ability to get FDA approval for related products.