Thermedx LLC: Medical Device Recall in 2015 - (Recall #: Z-1463-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 1, 2014

Date Posted: April 29, 2015

Recall Number: Z-1463-2015

Event ID: 69996

Reason for Recall:

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

Status: Terminated

Product Quantity: 127 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated