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Terminated

Alsius CoolGuard 3000 Temperature Regulation System, Model CoolGuard 3000

FDA Recall Z-1159-04 · Posted 2004-07-23

Recalling FirmAlsius Corporation
Recall StatusTerminated
Product CodeNCX
Date Initiated2004-06-21
Date Terminated2004-12-02
Product Quantity15

Reason for Recall

Higher than expected rate of pump alarms occur under specific conditions.

Firm Action

Firm replaced circuit board having a new resistor. Recall is complete.

Root Cause

Other

Distribution Pattern

MA, PA, VA, FL, AL, MO, TX

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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