Everyone involved in the C-arm business is aware of the GE/OEC shutdown, which went into effect just over a year ago.

Now OEC -- which by general consensus held about 65%-70% of the C-arm business before production was suspended in January of 2007 -- is awaiting word from the FDA on whether it can resume manufacturing operations.

For those not familiar with the situation, inspections conducted by the FDA during July and August 2006, revealed CGMP (current good manufacturing practices) deficiencies at facilities in Utah and Massachusetts. 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.
The voluntary consent decree suspending operations went into effect in January of 2007. That effectively shut down shipment of all OEC products, including the 9900 Elite C-Arm System, 9900 Elite NAV C-Arm System, 9800 C-Arm System, 2800 UroView System, 6800 MiniView System, Insta-Trak 3500 NAV System, and ENTrak 2500 NAV System, as well as their components and accessories.

The FDA is now reviewing the case. The FDA has until the end of the first week in April to make its decision known, but is free to make that announcement at any time, so it could come as early as next week.

Reliable sources have told DOTmed News that they have heard that workers have been called back by GE to OEC facility in Salt Lake City. These sources further told us that the first machines to resume production would be the 9900s.

DOTmed Business News will keep on top of this story and the minute the FDA decision comes down, we will report it in a "Breaking News" issue of DOTmed Weekly News.

Watch for it.

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