STERIS (NYSE:STE) has received 510(k) clearance from the U.S. Food and Drug Administration for software modifications to its System 1E liquid chemical sterilization system.
The modifications are related to system aborts that were caused primarily by water-temperature issues, STERIS spokesman Steve Norton said.
The System 1E is a liquid chemical sterilizing system used by hospitals, surgical centers and other healthcare facilities to sterilize heat-sensitive medical instruments. It’s a replacement device for the System 1.
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The FDA is requiring that customers transition away from the System 1 because it found in December 2009 that Mentor, Ohio-based STERIS had made so many changes to the device over the years that the agency hadn’t cleared the modified version of the device.
STERIS said it would begin shipping the modified System 1E and servicing units that have already been sold immediately, according to a regulatory filing. The “events” associated with the software modification won’t have a material impact on the company’s financial results for the year.
The company said it is still awaiting FDA clearance for one of the System 1E’s accessory parts, called a biological indicator. That part isn’t necessary to operate the device, though many customers prefer to use it. The part indicates the presence of biological materials on equipment.
STERIS reported last month that sales of the System 1E continue to lag earlier projections. At the time, the company also downwardly revised its full-year outlook for 2012.