FDA Medical Device Recalls (openFDA)
Thermedx LLC: 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
- 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.
- Status
- Terminated
- Initiated
- 2014-09-01
- Posted
- 2015-04-20
- Terminated
- 2015-09-14
- Reason
- To correct software bugs that could affect the ability to accurately measure fluid deficit.
- 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 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
- 127 units
- Distribution
- US Distribution to the states of : OH, MS, MA, WA, MI, NC, NY, WV, LA, TX and IL.
- Lot, serial or model codes
- Serial Numbers 20100001 through 20140044
- 510(k) numbers
- ["K091939","K133799"]
- PMA numbers
- not on file
- Product code
- HIG
- Firm FEI
- 3007495879
- Firm city
- Solon
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28