Company:Terumo Cardiovascular Systems Corporation Date of Enforcement Report 2/20/2013 Class ll: PRODUCT Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglobin levels. Recall Number Z-0802-2013 REASON Inaccurate readings. Software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations. The accuracy on any cuvette size...Read More

Company:Mindray DS USA, Inc. d.b.a. Mindray North America Date of Enforcement Report 2/20/2013 Class ll: PRODUCT Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgrade kit). The DPM Central Monitoring System transfers information between DPM Central station and...Read More

Company:GE Healthcare, LLC Date of Enforcement Report 2/20/2013 Class ll: PRODUCT GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monitor and accessories. Recall Number Z-0813-2013 REASON GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor. These issues may occur when the Ethernet controller in the XPC823 CPU on...Read More