WASHINGTON (Kyodo) The U.S. Food and Drug Administration said Tuesday it has warned Hitachi Medical Systems America Inc. over its failure to adequately report burns, hearing problems and other injuries to patients using magnetic resonance imaging systems produced by the Japanese parent firm.
“Failure to promptly correct these deviations may result in regulatory action being initiated by the Food and Drug Administration without further notice,” the FDA said in a July 13 letter to the Ohio-based sales unit of Hitachi Medical Corp., headquartered in Tokyo.
The letter was made public Tuesday.
“These actions include, but are not limited to, seizure, injunction, and/or civil money penalties,” the agency said.
The FDA issues many such warning letters regularly, and most cases are solved without further action. But the warnings are used by federal agencies when considering awarding contracts.
In the letter, the FDA said the specified cases “may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems.”
“You are responsible for investigating and determining the causes,” it said. “You also must promptly initiate permanent corrective and preventive action on your quality system.”
In one of the cases identified in the letter, the MRI system flashed an “unrecoverable error” message during the scan but continued to scan after the error, leading the head coil to come unlatched on the right side of the patient, burning him.
The company then received a written complaint from the patient July 2, 2004, that he suffered daily headaches in the area where the burns occurred.
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