An update was also issued here. According to the article, 15 days have been given to GE to respond. The full report and letter from the FDA can be viewed here. It appears the issues are relative to in-house software applications, but not limited as there were PACS issues and a few other issues, such as the maintenance of the Seibel data base (part of Oracle) that were mentioned in the letter. The letter states some of the responses were adequate, while others were not. It appears the FDA is attempting to do a pretty thorough audit to ensure software systems are reporting properly, again to make sure additional errors are not created. Technology is great and has answers to many issues, but technology also creates it own issues. 
Deluged today with the overflow of information, and clinicians have it two-fold, it is not uncommon for one's focus to either be distracted or interrupted. When reading the FDA letter, it appears there are some issues that remain in question. Software solutions are becoming increasingly complicated today and thus audits and re-checks should appear everywhere without a doubt, GE and any company offering software solutions. BD
WASHINGTON, Aug 19 (Reuters) - The U.S. Food and Drug Administration has warned GE Healthcare's Integrated IT Solutions unit for failing to keep proper records, according to documents released on Tuesday. The information technology unit, which makes various computer and software systems, also failed to establish proper procedures to review products, the FDA said in a warning letter dated Aug. 12.
Officials from the IT unit had responded in June to the FDA over the complaints, but some of the company's corrective actions were "inadequate," the agency wrote.
US FDA warns GE Healthcare IT unit over records | Markets | Markets News | Reuters
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