Recall Z-1619-2015 ยท GWM Device, Monitoring, Intracranial Pressure
Integra LifeSciences Corp.
The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The LCX02 monitor measures and displays oxygen partial pressure (Pt02) and temperature in brain tissue.
| Date | May 15, 2015 (initiated Apr 14, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | Integra initiated this recall by sending an Urgent Voluntary Medical Device Recall Letter/Recall Acknowledgement Form dated 4/14/15 via traceable courier service to their affected customers. |
| Quantity | 273 monitors |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |