Getinge is announcing a voluntary recall - correction of 46-Series Washer Disinfector in the U.S.

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.
 

Media contact:

Anna Appelqvist, Vice President Corporate Communications
Phone: +46 (0)10 335 5906
E-mail: anna.appelqvist@getinge.com

About Getinge

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions that aim to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 10,000 people worldwide and the products are sold in more than 135 countries.