Company:Siemens Medical Solutions USA, Inc
Date of Enforcement Report 2/8/12
Class ll:
PRODUCT
STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories. Recall # Z-0869-2012
REASON
Software deficiency. STERIS identified that water specifications were not being met at some of their customer sites. Critical parameters for initiating cycles are: water quality, water pressure and water temperature. Failure to meet these criteria may lead to cycle aborts by the SYSTEM 1E Liquid Chemical Sterilant Processing System. The firm intends to perform a software field correction which will enable the SYSTEM 1E to handle a wider range of user facility water characteristics.
RECALLING FIRM/MANUFACTURER
Steris Corporation Hopkins Facility, Mentor, OH, by letter dated December 8, 2011. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
3,882 units
DISTRIBUTION
Nationwide and Bahrain, Hong Kong, Japan and South Korea
