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Recall Observatory FDA recall evidence

Device product

The Integra Camino ICP Monitor is a compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The CAM02 monitor measures and displays intracranial ICP) and intracranial temperature (ICT).

Z-1618-2015

April 14, 2015

Class II

Product summary

Firm
Integra LifeSciences Corp.
Event
Event 71027
Status
Terminated
Classification
Class II
Quantity
1,482 monitors
Official record key
device-enforcement:Z-1618-2015

Official wording

Reason: Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM02) & 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

    reason.no_named_rule · v1.0.0

    Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible speaker malfunctions.