Apr

2015

Cl II Thermedx Fluid Management System P4000

Company:Thermedx LLC
Date of Enforcement Report: 4/29/2015
Class lI:

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.
Recall Number Z-1463-2015

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

RECALLING FIRM/MANUFACTURER
Thermedx LLC, Solon, OH on 9/1/2014 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
127 units

DISTRIBUTION
US Distribution to the states of : OH, MS, MA, WA, MI, NC, NY, WV, LA, TX and IL.

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl II Thermedx Fluid Management System P4000

Amy Sellers

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