GE Healthcare GmbH FDA Recalls

3 recalls on file across devices, 0 of them Class I and 3 still open. Matched by name to GEHC.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing systemClass IINov 3, 2025GE HealthCare has become aware that the Patient History tab	GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasou	Class IIDevices	Nov 3, 2025
ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, Class IIAug 8, 2024The National Institute of Standards and Technology (NIST) ha	The National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Databas	Class IIDevices	Aug 8, 2024
ViewPoint; system, imaging processing, radiologicalClass IIAug 8, 2024The National Institute of Standards and Technology (NIST) ha	The National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Databas	Class IIDevices	Aug 8, 2024