Medical Imaging News

January 31, 2007

GE OEC Medical Systems Signs Consent Decree with FDA

On January 12, the FDA announced that a consent decree of permanent injunction, related to X-ray surgical imaging systems, was signed by GE OEC Medical Systems Inc and its parent company, the General Electric Co—doing business as GE Healthcare—along with two of the company's top executives (Joseph M. Hogan, president and CEO of GE Healthcare; and Peter McCabe, president and CEO of GE OEC Medical Systems).

The decree—filed in the US District Court for the District of Utah and subject to court approval—prohibits the manufacturing and distribution of specified GE OEC Medical Systems X-ray surgical imaging systems at facilities in Salt Lake City and Lawrence, Mass, until each device is shown to be in compliance with the FDA's current good manufacturing practice (CGMP) requirements.

Specific systems include:

• the 9900 Elite C-Arm System;
• the 9900 Elite NAV C-Arm System;
• the 9800 C-Arm System;
• the 2800 UroView System;
• the 6800 MiniView System;
• the Insta-Trak 3500 NAV System; and
• the ENTrak 2500 NAV System.

According to the FDA's Center for Devices and Radiological Health (CDRH), the most recent inspection of the Utah facility revealed CGMP deficiencies, including 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.

A voluntarily recall was issued for several models of GE OEC Medical Systems' X-ray surgical imaging systems. Specific recall notices are available on the GE site. The same information also can be obtained by calling the company: (800) 874-7378 (option 8).

The full FDA release, including all actions required of GE, can be viewed online.

Read more Medical Imaging News from our archives