LICOX Brain Tissue Oxygen Monitoring Systems (2014-11-07) — recall 52624
Health Canada — Medical Devices · Canada · 2015-01-14 · Type III
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Reported risk: Integra Lifesciences initiated a recall to remove all affected LICOX probes and probe kits that may contain an inaccurate smart cards supplied with the subject devices. The IKN2 value in approximately 90% of the potentially affected cards is approximately 10 times higher than it should be resulting in varying degrees of understated PO2 values (from -1 mm of Hg to -7 mm of Hg) when the probes are used.
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