FDA gives Steris more time to replace System 1 processer

By: March 24th, 2011 Email This Post Print This Post

In the long battle starring Steris Corp.’s System 1 processor, the FDA has extended the life of the processor and given healthcare providers until February 2, 2012, to replace it.

The System 1 processor  has been in the spotlight since the FDA issued its first warning in December 2009 . Since then, STERIS has been working to transfer its customers to the new System 1E product, reports medcitynews.com.

STERIS reported that it asked the FDA for an extension while the agency is looking over a 510(k) application for a replacement part, reports Medcitynews.com. The application for the part was filed sometime after April 2010, though the part isn’t a necessity to activate the System 1E.

To read more about the FDA’s concerns and IC tips for healthcare facilities, take a look at OSHA Healthcare Advisor’s reports.

 

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