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Terminated

Alsius CoolGard 3000 Temperature Regulation System

FDA Recall Z-1397-05 · Posted 2005-08-24

Recalling FirmAlsius Corporation
Recall StatusTerminated
Product CodeNCX
Date Initiated2005-07-25
Date Terminated2007-01-31
Product Quantity207

Reason for Recall

Firm wants users to be aware not to leave the units in standby mode for more than an hour in rooms in excess of 75 F due to risk of an alarm mode being generated due to overheating.

Firm Action

Firm will be sending letters of caution to all users that reemphasizes labeling beginning 7/25/2005. New software is being developed which will include a change to maintain STANDBY coolant temperature regulation indefinitely, removing any risk of failure.

Root Cause

Other

Distribution Pattern

Nationwide and in Uruguay, Netherlands, Switzerland, Spain, Poland, China, Norway, Malasia, Italy, Ireland, greece, Germany, France, Finland, Canada, Belgium, Austria, Bahamas,

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030421ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEMAlsius Corp. · 2003-10-23K014241COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500DAlsius Corp. · 2003-08-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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