FDA-Device2015-04-29Class II
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.
Thermedx LLC
Hazard
To correct software bugs that could affect the ability to accurately measure fluid deficit.
Sold states
US Distribution to the states of : OH, MS, MA, WA, MI, NC, NY, WV, LA, TX and IL.
Affected count
127 units
Manufactured in
31200 Solon Rd, Unit 1, Solon, OH, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1463-2015Don't want to check this manually?
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