Last Friday, May 2nd, DOTmed Online News was the first news organization to break the story that GE's OEC division (which is part of GE Healthcare Surgery) received notification from the U.S. Food and Drug Administration (FDA) that OEC has met the requirements under the January 2007 consent decree to resume regular production.

GE further told DOTmed at that time that OEC could not ship until the FDA approved their 510(k) request for pre-market clearance.

GE received that OK this Monday, May 5th.
The first product out the door will be the 9900 Elite C-arm. OEC expects to ship 300 by mid-May, and then ship 50 units a week for the foreseeable future until their backlog of orders is filled.

"This is a great day for our customers," observed Joe Hogan, President and CEO of GE Healthcare. "We'd like to thank the thousands of hospitals that stood by and waited with us, believing in our product and our team. We can assure them, with the refinements we have made to our Surgery business' Quality Management System and the OEC 9900 C-arm, we have raised our own standards, creating a foundation that will serve our customers well into the future."

"Coming out of this, we're a better business," remarked Pete McCabe, President and CEO of GE Healthcare Surgery. "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. We look forward to again being a leader in this highly competitive field."

OEC asserts that it has improved its manufacturing quality assurance program, and that the new 9900s coming out of their Salt Lake City facility are "the best quality C-arms GE/OEC has ever made," according to Pete McCabe.

For GE's OEC website go here: OEC Shipping.

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