Company:GE Medical SystemsDate of Enforcement Report 4/22/2009 Class:ll PRODUCT a) GE Healthcare Infinia, Model Numbers: a) ASM000886, b) ASM001333, c) ASM001391, d) ASM001465, e) ASM001473, f) ASM001620, g) ASM500016, h) H3000WM, i) H3000WT, j) H3000WY and k) SYS000041. Product is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in...Read More

Company:Smiths Medical MD, IncDate of Enforcement Report 4/22/2009 Class:ll PRODUCT a) Deltec Cozmo Insulin Pump, Model 1800. Deltec Cozmo Insulin Pumps are ambulatory electromechanical pumps used for delivering insulin to patients with diabetes. The pump is used mainly by homecare patients but, can also be used in a healthcare facility, Recall # Z-0988-2009; b) Deltec...Read More