Recall Z-1463-2015— Thermedx LLC
Class II · Terminated
Class II FDA medical device recall by Thermedx LLC, initiated 2014-09-01, terminated 2015-09-14. It names 2 FDA 510(k) clearances: K133799, K091939. 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.. Reason: To correct software bugs that could affect the ability to accurately measure fluid deficit..
- Recalling firm
- Thermedx LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-09-01
- Terminated
- 2015-09-14
- Firm location
- Solon, OH, United States
510(k) clearances named in this recall
2 on FDA's record- K133799 — THERMEDX FLUID MANAGMENT SYSTEM
- K091939 — THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Reason for recall
To correct software bugs that could affect the ability to accurately measure fluid deficit.
Data sourced from openFDA. This site is unofficial and independent of the FDA.