Company:Thermedx LLCDate of Enforcement Report: 4/29/2015 Class lI: PRODUCT Fluid Management System P4000; for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic procedures. Recall Number Z-1463-2015 REASON To correct software bugs that could affect the ability to accurately measure fluid deficit.....Read More

Company: Del Mar Reynolds Medical, Ltd.Date of Enforcement Report: 4/29/2015 Class lI: PRODUCT Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00. This kit is for Spacelabs Healthcare Blease 700/900 Series Ventilators. Designed specifically for the mechanical ventilation of adult and pediatric patients under general anesthesia. Recall Number Z-1458-2015 REASON Reports of inaccurate low flow readings. Monitored...Read More