The Recall Desk
HighFDA (Devices)·Z-1463-2015·Announced 2015-04-29

Thermedx Fluid Management System P4000 Recalled for Software Bugs

Thermedx LLC is recalling 127 Fluid Management System P4000 units due to software bugs that could affect the accuracy of fluid deficit measurements.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a defect that could lead to inaccurate measurements, posing a risk of harm to patients, but no injuries or illnesses have been reported.

Plain-English summary

Thermedx LLC is recalling 127 units of the Fluid Management System P4000. This medical device is used for irrigation, fluid warming, and volume/deficit measurements in laparoscopic and endoscopic procedures within gynecology, urology, and orthopedic fields.

The recall is being conducted to correct software bugs that could affect the device's ability to accurately measure fluid deficit. The affected units have serial numbers ranging from 20100001 through 20140044.

The recalled products were distributed in the United States to the states of Ohio, Mississippi, Massachusetts, Washington, Michigan, North Carolina, New York, West Virginia, Louisiana, Texas, and Illinois. Healthcare facilities and users should stop using the affected devices and contact Thermedx LLC for further instructions.

The recalled product

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
Thermedx LLC
Category
Medical Device — Surgical Equipment
Hazard
Affected units
127

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial Numbers 20100001 through 20140044

Distribution

Distributed in 11 states:

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