Company:Sigma Date of Enforcement Report 7/25/12 Class lll: PRODUCT SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of all IV and epidural drugs, along with their safe delivery parameters. Recall Number Z-2030-2012 REASON Sigma is a safety alert for the Master Drug Library (MDL) Editor software associated with...Read More

Company:Hitachi Medical Systems America Inc. Date of Enforcement Report 7/25/12 Class ll: PRODUCT Hitachi Scenaria CT System Software Product Usage: The Scenaria system is indicated to acquire axial volumes of the whole body including the head. The images can be acquired in either axial, helical, gated or dynamic modes. The volume datasets acquired by the...Read More

Company:GE Healthcare Date of Enforcement Report 7/25/12 Class ll: PRODUCT GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take exposures utilizing film or computed radiography ( CR ) Recall Number Z-1993-2012 REASON GE Healthcare hos become aware of o software issue on the interfoce of the...Read More