The U.S. Food and Drug Administration said Tuesday it has warned Hitachi Medical Systems America over its failure to adequately report burns, hearing problems and other injuries to patients using magnetic resonance imaging systems produced by its 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. Regulatory actions could include "seizure, injunction, and/or civil money penalties," according to the agency.
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 Hitachi is responsible for investigating the causes of the injuries and initiating "corrective and preventive action."