ClearanceBrief
Recall Z-1159-04 ยท NCX System, Hypothermia, Intravenous, Cooling

Alsius Corporation

Alsius CoolGuard 3000 Temperature Regulation System, Model CoolGuard 3000

DateJul 23, 2004 (initiated Jun 21, 2004)
StatusTerminated
ReasonHigher than expected rate of pump alarms occur under specific conditions.
Root causeOther
ActionFirm replaced circuit board having a new resistor. Recall is complete.
Quantity15
DistributionMA, PA, VA, FL, AL, MO, TX
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