Getinge has responded to FDA and accepted that Datascope will be included in the existing Consent Decree. FDA's conclusion relates to a previously communicated warning letter in 2019 and subsequent inspections at the Datascope site in Wayne, NJ, US, between November 1, 2021 and January 21, 2022. According to FDA, Getinge's subsidiary Datascope has failed to fully comply with the Quality Management System and related processes. Datascope is enforcing the ongoing actions to address the findings from the inspections and warning letter and to ensure that the organization act in compliance with the Quality Management System.

The company is implementing a new operational quality organization with new leadership closer and integrated in the business operations. A work plan for further improvements for the site will be submitted to FDA in January 2023, in accordance with standard procedure and an independent auditor will be appointed. Datascope's improvement activities 2018-2022 amount to approx.

SEK 500 million from 2018. The additional costs for the improvements going forward are not expected to be material.