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All product recalls affecting Rhode Island.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Rhode Island in the distribution area.
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.
Potential issue where the IntelliVue monitors did not alarm.
Potential issue where the IntelliVue monitors did not alarm.
Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.