DEKRA temporarily suspends certificates for Getinge’s HLS and PLS sets
The notified body for certification services, DEKRA, has decided to temporarily suspend the CE-certificates for Getinge’s HLS and PLS sets from March 1, 2023. Getinge is in dialogue with authorities and working urgently to minimize the impact on patients.As previously communicated, Getinge has identified and announced potential breaches in sterile packaging of the HLS and PLS sets used for extracorporeal respiratory and/or cardiovascular support. Getinge has since then reported progress to relevant authorities on a number of initiatives, such as package design improvements and advanced