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
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
software bugs that could