The FDA granted approval today for GE Healthcare’s surgery unit to resume operations and begin shipping its OEC 9900 Elite C-arm, a fluoroscopy device.
More than 300 of the units will be shipped to customers in the first 10 days of operations, the company said.
On May 1, GE’s surgery unit received notification from the FDA that it had met the requirements under the January 2007 consent decree to resume regular production and distribution operations, Corey Miller, public relations, GE Healthcare told Health Imaging News.
The approval marked the end of a 20-month shutdown that stemmed from the FDA’s finding that device malfunctions were not being reported, according to the Wall Street Journal (WSJ). The factory accounted for about 90 percent of the unit’s business, which has annual sales of about $600 million.
“Coming out of this, we’re a better business,” remarked Pete McCabe, President and CEO of GE Healthcare Surgery. “The OEC 9900 C-arm is the most reliable product produced in our business’ 30-year history. Our quality system, alongside customer focus and technical innovations, is a foundation of our business. In the last year, we’ve been able to strengthen it to levels that will ensure we continue to differentiate our products and services as the best in the marketplace.”