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Thermedx LLC recalls Fluid Management System P4000; for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warmi
Recalled April 29, 2015 · FDA recall Z-1463-2015 · Thermedx
Hazard
To correct software bugs that could affect the ability to accurately measure fluid deficit. · FDA Class II
Units
127 units
Sold at
US Distribution to the states of : OH, MS, MA, WA, MI, NC, NY, WV, LA, TX and IL.
Description
To correct software bugs that could affect the ability to accurately measure fluid deficit.
Product
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.
Manufacturer(s)
Thermedx LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →