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Health product recall

Camino Advanced Monitor (2013-11-27)

Starting date:
November 27, 2013
Posting date:
January 6, 2014
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-37281

Recalled products

  1. Camino Advanced Monitor 

Reason

Integra Lifesciences has identified that if the optional SYS/DIAS mode is used on Camino advanced monitors (CAM01) with serial numbers formatted as MExxxxx04, the displayed values for the systolic and diastolic intracranial pressure (ICP) are reversed. But, if the CAM01 is used with an auxiliary bedside monitor, the bedside monitor displays these values correctly.

Affected products

A. Camino Advanced Monitor

Lot or serial number
  • MEA1301804
  • MEC1300404
  • MED1301104
  • MED1301204
  • MED1301304
  • MEE1300504
  • MEE1301504
Model or catalog number
  • CAM01
Companies
Manufacturer

Integra Neurosciences Ltd.

also trading as Spembly Medical

Newbury Road

Andover, Hampshire

SP10 4DR

UNITED KINGDOM