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Terminated

Alsius CoolGard 3000 patient temperature regulation system

FDA Recall Z-0258-05 · Posted 2004-11-25

Recalling FirmAlsius Corporation
Recall StatusTerminated
Product CodeNCX
Date Initiated2004-11-10
Date Terminated2005-01-12
Product Quantity2

Reason for Recall

Product alarms that there may be a power supply interruption.

Firm Action

Firm removed products from use for repair on 11/10/2004.

Root Cause

Other

Distribution Pattern

IL and NC. Specifically, Rush University Medical Center, Chicago IL and Duke University medical Center, Durham NC.

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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