Getinge is announcing a medical device correction of the 46-Series Washer Disinfectors in the U.S due to a missing water intake for Deionized water (DiW). Getinge has reported to relevant authorities according to applicable regulations and the cost for the recall is not material.
Getinge has identified during installation that 11 units have been delivered to end users without water intake for Deionized water (DiW). The product non-conformity presents a potential delay in installation of the device at the end user facility and/or potential procedure delay in the customer’s workflow. The units affected by this recall were not used on a patient and there have been no adverse events reported resulting in serious illness or injuries caused by the Getinge 46-Series Washer Disinfector issue. All affected customers have received communication from Getinge.
This information is released in order to inform users of mentioned Getinge products, according to standard procedures recommended by regulatory authorities.
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