GE Healthcare of Chalfont St. Giles, U.K., has halted the manufacturing and distribution of surgical C-arms after the U.S. Food and Drug Administration (FDA) expressed concerns over current good manufacturing practices (CGMPs) at the facilities where the systems are made.
In a news release on January 12, the FDA said that company executives have signed a consent decree agreeing to the halt, which affects systems made by its GE OEC Medical Systems unit at facilities in Salt Lake City and Lawrence, MA. The FDA said its most recent inspection of the Salt Lake City facility, in July and August 2006, revealed CGMP deficiencies that include "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 Salt Lake City facility had received a warning letter from the FDA in March 2005, citing violations of CGMP requirements. The FDA issued its consent decree because it felt GE's response to corrections requested in the 2005 warning letter was inadequate.
The consent decree requires GE "to take necessary measures to ensure that the x-ray surgical imaging systems manufactured and designed at the Utah and Massachusetts facilities comply with CGMP requirements, as well as FDA regulations for reporting adverse events and malfunctions and device corrections and removals."
GE must also hire an independent expert to conduct inspections of the Utah and Massachusetts facilities, and certify to the FDA that corrections have been made. Manufacturing and distribution from the facilities can resume once the corrections have occurred, the FDA said. An outside expert will also conduct yearly inspections for four years to ensure that the facilities remain in compliance.
The manufacturing and distribution halt affects products including 9900 Elite, 9900 Elite NAV, 9800, 2800 UroView, 6800 MiniView, Insta-Trak 3500 NAV, and ENTrak 2500 NAV, as well as their components and accessories. GE can continue to produce replacement parts and accessories and to conduct service for surgical C-arms that are already installed.
By AuntMinnie.com staff writers
January 16, 2007
Related Reading
GE lands Mississippi Senographe install, January 12, 2007
ART, GE extend eXplore Optix pact, December 22, 2006
GE installs first Discovery STE in Canada, December 21, 2006
GE nets New York EMR contract, December 8, 2006
GE places Centricity in Oakland, December 6, 2006
Copyright © 2007 AuntMinnie.com
