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Terminated

Alsius CoolGard Temperature Regulation System

FDA Recall Z-0369-06 · Posted 2006-01-10

Recalling FirmAlsius Corporation
Recall StatusTerminated
Product CodeNCX
Date Initiated2005-11-09
Date Terminated2007-02-05
Product Quantity239

Reason for Recall

Alsius has found that fluid spills or ingress may result in an alarm condition. The potential health risk involved in this state can be the discontinuance of therapy.

Firm Action

Alsius Corporation is notifying customers of an issue requiring service of their CoolGard 3000 by letter shipped via FEDEX and DHL. Verification of receipt of the notification letter to level A will be undertaken by using tracked delivery requiring signature upon receipt.

Root Cause

Other

Distribution Pattern

Nationwide and in Uruguay, Netherlands, Switzerland, Spain, Poland, China, Norway, Malaysia, Italy, Ireland, Greece, Germany, France, Finland, Canada, Belgium, Austria, Bahamas, and United Kingdom

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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