Health Canada — Medical Devices · Canada · 2017-07-17 · Type II
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Reported risk: A customer complaint from Heartsine's Canadian distributor, Rescue 7, was received questioning why a SAM 350P, serial number 17D00009917, was labelled with an Omron Raing label. (Note: As well as the SAM 350p, Heartsine also manufacture a similar device for a Japanese customer, Omron. This Japanese device is referenced as the Omron HDF-3500 device. The rear label specific to the Omron HDF-3500 device is H045-013-013-1).
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