Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 5/6/2015 Class lI: PRODUCT Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375, Global Trade Item Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Global Trade Item Number 10758750001644; IVD. Intended for use in the in vitro quantitative, semi quantitative, and...Read More

Company: Spacelabs Healthcare IncDate of Enforcement Report: 5/6/2015 Class lI: PRODUCT Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in...Read More

Company: Nihon Kohden America Inc.Date of Enforcement Report: 5/6/2015 Class lI: PRODUCT Remote Network Station, Catalog RNS-9703, Model No. RNS-9703-19, RNS-9703-24, Software version 02.40. The RNS 9703 is intended for use by medical professionals to provide secondary cardiac and vital signs monitoring for multiple patients within a medical facility. The device will display physiological data...Read More

Company: Lumenis Limited.Date of Enforcement Report: 5/6/2015 Class lI: PRODUCT Light Sheer Desire Diode Laser System with XC Handpiece Accessory options. Recall Number Z-1519-2015 REASON Device software treatment preset parameters for the XC treatment handpiece do not match the Operator Manual, and exceed recommended settings. Operator Manual parameters are lower than indicated for specific hair...Read More

Company: Dako North America Inc.Date of Enforcement Report: 5/6/2015 Class lI: PRODUCT Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the Dako Omnis System, an automated slide stainer for in vitro diagnostic use. The TRD is intended to distribute patient case, appropriate parts information, track changes, and transform test requests...Read More

Company: Steris CorporationDate of Enforcement Report: 5/6/2015 Class lI: PRODUCT AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation. AMSCO C Small Sterilizer, AMSCO 400 Small Sterilizer, AMSCO 400 Medium Sterilizer. Designed for sterilization of heat and moisture-stable materials used in healthcare facilities. Recall Number Z-1561-2015 REASON STERIS has identified that the control board software...Read More