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Recall Observatory FDA recall evidence

Device 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.

Z-1463-2015

September 01, 2014

Class II

Product summary

Firm
Thermedx LLC
Event
Event 69996
Status
Terminated
Classification
Class II
Quantity
127 units
Official record key
device-enforcement:Z-1463-2015

Official wording

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

Code information: Serial Numbers 20100001 through 20140044

Distribution pattern: US Distribution to the states of : OH, MS, MA, WA, MI, NC, NY, WV, LA, TX and IL.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software bugs that could