Device product
The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The LCX02R monitor measures and displays oxygen partial pressure and temperature in tissue.
Z-1620-2015
Product summary
- Event
- Event 71027
- Status
- Terminated
- Classification
- Class II
- Quantity
- 59 monitors
- Official record key
device-enforcement:Z-1620-2015
Official wording
Reason: Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM 02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible speaker malfunctions.
Code information: All Lots
Distribution pattern: Worldwide Distribution.
Derived failure modes
-
Unknown
Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM 02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible speaker malfunctions.