GE OEC Medical Systems and GE Healthcare have signed a consent decree of permanent injunction related to X-ray surgical imaging systems manufactured by GE OEC Medical Systems. GE is the parent company of CNBC.
The U.S. Food and Drug Administration (FDA) says the consent decree prohibits the manufacturing and distribution of specified GE OEC Medical Systems X-ray surgical imaging systems at facilities in Utah and Massachusetts until the devices and facilities are in compliance with the FDA's requirements.
The decree was filed Friday in the U.S. District Court for the District of Utah and is subject to court approval.
FDA's most recent inspection of the Utah facility, revealed deficiencies. These included failure to establish and maintain adequate procedures for validating the device design and failure to establish and maintain adequate procedures for implementing corrective and preventive actions.
Under the terms of the consent decree, the companies have agreed to take necessary measures to ensure that the X-ray surgical imaging systems manufactured and designed at the Utah and Massachusetts facilities comply with requirements, as well as FDA regulations for reporting adverse events and malfunctions and device corrections and removals.
The decree also requires that the companies hire an independent expert to conduct inspections of GE OEC Medical Systems facilities in Utah and Massachusetts and certify to FDA that corrections have been made.