ClearanceBrief
Recall Z-0258-05 ยท NCX System, Hypothermia, Intravenous, Cooling

Alsius Corporation

Alsius CoolGard 3000 patient temperature regulation system

DateNov 25, 2004 (initiated Nov 10, 2004)
StatusTerminated
ReasonProduct alarms that there may be a power supply interruption.
Root causeOther
ActionFirm removed products from use for repair on 11/10/2004.
Quantity2
DistributionIL and NC. Specifically, Rush University Medical Center, Chicago IL and Duke University medical Center, Durham NC.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K014241COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D
Alsius Corp., Aug 1, 2003
K030421ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM
Alsius Corp., Oct 23, 2003