The QMN Weekly Bulletin

GE Healthcare Slapped With Warning Letter Citing CAPAs in IT Division

Sept. 19, 2008
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GE Healthcare’s Integrated IT Solutions division has inadequate corrective and preventive action (CAPA) procedures for its Centricity Imaging and Picture Archiving and Communication Systems software packages, according to an FDA warning letter.

The systems are used to access study worklists, patient folders, diagnostic reports, radiology and cardiology images and physician and department information.

The letter, issued Aug. 12 and posted recently to the FDA’s website, is the third GE Healthcare has received in the past year and a half. The company told MQN that the two previous warning letters have been resolved.

The most recent warning letter says the firm’s IT division does not have procedures to evaluate all data sources for CAPAs, such as its complaint-handling system, service data and system performance reports.

“In October 2007, GE Medical Systems in France submitted a correction and removal report for safety issues identified in their Advantage Workstation (AW) product. The evaluation of the same safety issues identified in the GE Healthcare IITS AW Suite version 2.0.1 product (which builds on the AW software code) did not include the consideration that the site in France initially reported these issues,” the letter says.

The warning letter can be accessed at www.fda.gov/foi/warning_letters/s6881c.pdf.