Fluid Management System P4000 recallZ-1463-2015 · Thermedx LLC · initiated Sep 1, 2014
Class II Terminated All recalls posted in April 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Thermedx LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
To correct software bugs that could affect the ability to accurately measure fluid deficit.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-1463-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Sep 1, 2014
- Posted by the FDA
- Apr 20, 2015
- Recalling firm
- Thermedx LLC
- Quantity
- 127 units
- Product code
- HIG
- FDA submissions
- K091939, K133799
- 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.
Code information (models, lots, serial numbers)
Serial Numbers 20100001 through 20140044
Other devices under the same FDA submission
1 device cleared under K091939, K133799 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Fluid Management System P2000Thermedx, LLC · Arthroscope1 death4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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