FDASeptember 1, 2014device

Fluid Management System P4000; for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic procedures.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

To correct software bugs that could affect the ability to accurately measure fluid deficit.

What to do

FDA enforcement status: Terminated

Brands named

thermedx

Recall history

No related federal recalls on record for this brand yet.

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