Press release Gothenburg, Sweden, on December 22, 2021
Getinge informs about FDA Letter to Healthcare Providers related to Intra-Aortic Balloon Pumps
American Food & Drug Administration (FDA) has published today an updated reminder to health care providers related to previously communicated notifications connected to field corrections of Intra-Aortic Balloon Pumps.
The updated reminder concerns devices running on AC power with only one battery, unexpected short battery runtime and fluid ingress. Customers have been previously informed according to the regular field correction process and information about the updated reminder can be found on FDAs website.
The communication from FDA was published today to remind healthcare providers to ensure proper use of devices and the health and safety of patients. There are no material costs for Getinge associated with the notifications.
Anna Appelqvist, Vice President Corporate Communications
Phone: +46 (0)10 335 5906
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.