TÜV SÜD suspends CE-certificate for Getinge’s Cardiosave
The notified body for certification services, TÜV SÜD, has decided to suspend the CE-certificate for Getinge’s Intra-Aortic Balloon pump Cardiosave, effective immediately. The company has been given three months to adhere to the required corrective actions.The notified body, TÜV SÜD, has issued an immediate suspension of the CE certificate for intra-aortic balloon pumps for up to three months. The suspension is based on concerns related to risk management, post market surveillance and vigilance, as well as information pertaining to timeliness of field safety corrective actions. During