由于持续存在的安全和质量问题,FDA 警告医疗保健提供商不要使用 Getinge/Maquet 心血管设备。 FDA warns healthcare providers against using Getinge/Maquet cardiovascular devices due to ongoing safety and quality concerns.
由于持续存在的安全和质量问题,FDA 警告医疗保健提供者不要使用某些 Getinge/Maquet 心血管设备,例如 Cardiosave Hybrid 和 Rescue 主动脉内球囊泵。 The FDA warns healthcare providers against using certain Getinge/Maquet cardiovascular devices, such as the Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps, due to ongoing safety and quality concerns. Getinge 已采取纠正措施,但 FDA 仍继续收到与设备问题相关的报告。 Getinge has taken corrective measures, but the FDA continues to receive reports related to device issues. 建议医疗保健提供者尽可能地摆脱这些设备,并在使用时遵循特定的建议。 Healthcare providers are advised to transition away from these devices if possible, and follow specific recommendations when using them. Getinge 已针对 Cardiosave IABP 发出 12 次自愿召回通知,并针对 Cardiohelp 系统和 HLS 套件发出 8 次自愿召回通知。 Getinge has issued 12 voluntary recalls for the Cardiosave IABP and 8 for the Cardiohelp system and HLS set.