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U.S. Department of Health and Human Services

Class 2 Device Recall Fluid Management System P4000

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  Class 2 Device Recall Fluid Management System P4000 see related information
Date Initiated by Firm September 01, 2014
Date Posted April 20, 2015
Recall Status1 Terminated 3 on September 14, 2015
Recall Number Z-1463-2015
Recall Event ID 69996
510(K)Number K091939  K133799  
Product Classification Insufflator, hysteroscopic - Product Code HIG
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.
Code Information Serial Numbers 20100001 through 20140044
Recalling Firm/
Thermedx LLC
31200 Solon Rd
Unit 1
Solon OH 44139-3556
For Additional Information Contact Customer Service Department
Manufacturer Reason
for Recall
To correct software bugs that could affect the ability to accurately measure fluid deficit.
FDA Determined
Cause 2
Software design
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.
Quantity in Commerce 127 units
Distribution US Distribution to the states of : OH, MS, MA, WA, MI, NC, NY, WV, LA, TX and IL.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HIG and Original Applicant = THERMEDX LLC
510(K)s with Product Code = HIG and Original Applicant = THERMEDX, LLC