Events

Recall of Fluid Management System P4000

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Thermedx LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69996
  • Event Risk Class
    Class 2
  • Event Number
    Z-1463-2015
  • Event Initiated Date
    2014-09-01
  • Event Date Posted
    2015-04-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132087
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Insufflator, hysteroscopic - Product Code HIG
  • Reason
    To correct software bugs that could affect the ability to accurately measure fluid deficit.
  • Action
    Thermedx sent an Urgent Product Correction letter dated March 13. 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm informed their customers that the software update will be performed at customer locations by Thermedx trained and authorized personnel. A Thermedx and/or your Sales Representative will contact customers to schedule a time to perform the field service update. Should you have any questions regarding this notification, please call a Thermedx technical service representative. Support is available toll free at 1-888-542-9276 from 8AM to 5PM Monday to Friday Eastern Standard Time or by e-mailing techservice@thermedx.com. Our website may be found at www.thermedx.com. We sincerely apologize for the inconvenience and thank you in advance for your cooperation.

Device

Fluid Management System P4000
  • Model / Serial
    Serial Numbers 20100001 through 20140044
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : OH, MS, MA, WA, MI, NC, NY, WV, LA, TX and IL.
  • 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.
  • Manufacturer
    Thermedx LLC

Manufacturer

Thermedx LLC
  • Manufacturer Address
    Thermedx LLC, 31200 Solon Rd, Unit 1, Solon OH 44139-3556
  • Manufacturer Parent Company (2017)
    Thermedx LLC
  • Source
    USFDA