Steris System 1 Processor: Extension of Recommended Time Period for Healthcare Facilities to Transition to Legally-Marketed Alternatives
MedSun: Newsletter #46, March 2010

FDA Medical Device Safety website

FDA is extending to 18 months from the date of this notice the total recommended time period for transitioning from Steris Corporation's modified System 1 processor (SS1) to legally-marketed alternative devices. As FDA announced in its December 3, 2009, notice, the Agency has not approved or cleared the SS1 for its labeled claims. Steris Corporation has chosen not to seek FDA clearance of this device and, therefore, its use should be discontinued as soon as practicable.

Additional Information:

Medical Device Safety website. Information About STERIS System 1. Februrary 23, 2010.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm194411.htm

FDA Medical Device Safety website. Steris System 1 Processor: Extension of Recommended Time Period for Healthcare Facilities to Transition to Legally-Marketed Alternatives. February 2, 2010.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm199567.htm


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