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All product recalls affecting Arkansas.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Arkansas in the distribution area.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete patient medical history information.
Distribution without premarket approval/clearance.
Labeling contains claims that are not consistently present.