Z-1463-2015Class II

Fluid Management System P4000; for irrigation and fluid warming in laparoscopic procedures, and distention...

Name: Z-1463-2015 Fluid Management System P4000; for irrigation and fluid warming in laparoscopic procedures, and distention...
Creator: Thermedx LLC
Published: 2014-09-01
License: https://open.fda.gov/license/

Thermedx LLC / initiated 2014-09-01 / Terminated / root cause: software

FDA source

Thermedx LLC began a recall of Fluid Management System P4000; for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in... on 2014-09-01. FDA classified it as Class II and gives the reason as "To correct software bugs that could affect the ability to accurately measure fluid deficit". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1463-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-01
Posted: 2015-04-20
Terminated: 2015-09-14
Recalling firm: Thermedx LLC
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.
Product code: HIG Insufflator, Hysteroscopic
Reason for recall: To correct software bugs that could affect the ability to accurately measure fluid deficit.
Root cause tag: software
FDA root cause: 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 [email protected]. 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.
Product codes and lots: Serial Numbers 20100001 through 20140044

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1463-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1463-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-29	2015-04-20

Product code HIG

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)