Diagnostic Equipment

GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.

GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

Due to incorrect/lack of Unique Device Identifier (UDI) codes.

IV sets may leak.

IV sets may leak.

IV sets may leak.

IV sets may leak.

IV sets may leak.

A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.

IV sets may leak.

IV sets may leak.

IV sets may leak.

IV sets may leak.

IV sets may leak.

IV sets may leak.

IV sets may leak.