Health Canada — Medical Devices · Canada · 2012-12-24 · Type II
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Reported risk: A single occurrence of a cross wired appliance connector within a Carestream DRX-1 system console was discovered during system testing prior to shipment. Carestream has determined that a field inspection is necessary to ensure there are no consoles in the field with the cross wiring configuration. If a cross wired console is in use, under the combination of circumstances where a facility does not have an intact electrical ground, an operator or service person is touching the console and another grounded surface, there could be a risk of severe electrical shock. This type of event is very unlikely as all of these circumstances must be true in order for the hazard to manifest.
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