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GE halts production of certain X-ray systems while the company fixes manufacturing problems.

General Electric Co.'s health care unit and U.S. regulators said they have reached a legal agreement that halts production of certain X-ray systems while the company fixes manufacturing problems.

The Food and Drug Administration (FDA) said the deal with GE Healthcare and two executives applied to X-ray devices made by the GE OEC Medical Systems unit in Salt Lake City, Utah, and Lawrence, Massachusetts.

Government inspectors found production of the devices did not meet federal manufacturing standards, the FDA said. The agency warned the company about deficiencies in a March 2005 letter, but inspections in August 2006 found the firm's responses inadequate, the FDA said.

GE Healthcare voluntarily stopped shipping the devices in September 2006, company spokesman Brian McKaig said.

Under the new deal, GE agreed not to make or distribute certain X-ray devices from the two plants until the FDA is satisfied that problems have been solved, the agency said. The agreement is subject to court approval.

"These devices are used on thousands of patients, and their dependability and accuracy are critical," Dr. Daniel Schultz, director of FDA's Center for Devices and Radiological Health, said in a statement.

GE Healthcare, in a statement, said it took the FDA's findings seriously and "continues to work aggressively to address and resolve the issues identified as quickly as possible".

Devices under the agreement include the 9900 Elite C-Arm System, 9900 Elite NAV C-Arm System and 9800 C-Arm System.

Sales of the affected products accounted for less than 1 percent of total revenue for GE overall, McKaig said. GE is a diversified company with operations ranging from jet engines to NBC Universal media.