GE Healthcare Recalls

Hazard: Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).

Hazard: The placing of weight on the VRAD detector, of the Brivo XR385 digital radiographic system, can introduce image artifacts, which can result in patient exam retakes.

Hazard: Potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer.

Hazard: Potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer.

Hazard: A database handling error could occur during the image acquisition process affecting the completeness of acquired images with Centricity PACS-IW. There is a potential that one or more image series (i.e. all images within an image set) may be missing from an exam without indication to the user. While this is rare, this can occur with imaging studies that consist of a very small number of images per series. E.g. CR Thorax exam with 1 image per series.

Hazard: if the cables of the Monica IF24 System are removed by a user, and then incorrectly re-connected the Fetal Heart Rate (FHR) and Maternal Heart Rate (MHR) signals would be displayed incorrectly (swapped).

Hazard: if the cables of the Monica Novii System are removed by a user, and then incorrectly re-connected the Fetal Heart Rate (FHR) and Maternal Heart Rate (MHR) signals would be displayed incorrectly (swapped).

Hazard: Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.

Hazard: Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.

Hazard: Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction

Hazard: GE Healthcare has recently become aware of a potential safety issue related to loose screws in the Heater Head of the Infant Warmer System (IWS). Hot screws from the Heater Head of the IWS could fall onto the bed if the Heater Head assembly has been improperly serviced. This situation can be clinically hazardous because thermal injury to a patient could result. Two injuries have been reported as a result of this issue.

Hazard: It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Hazard: It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Hazard: It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Hazard: It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Hazard: It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Hazard: It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Hazard: It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Hazard: It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Hazard: It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Hazard: It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Hazard: It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Hazard: It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Hazard: It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Hazard: It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Hazard: It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Hazard: It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Hazard: Reported incidents of a patient step detaching from the table. A fall from a patient step detaching while in use could result in an injury to a patient or operator.

Hazard: GE Healthcare has become aware of an issue where a patient other than the intended is incorrectly selected by the operator in situations where DICOM Worklist search response time is slow. This issue is limited to certain Vivid Ultrasound systems and can result in the incorrect patient information showing on the screen during the exam. If not detected by the operator, images from the actual (intended) patient will be stored under the incorrect patient after the exam. This issue could lead to misdiagnosis. There have been no injuries reported because of this issue.

Hazard: GE Healthcare has become aware of an issue where a patient other than the intended is incorrectly selected by the operator in situations where DICOM Worklist search response time is slow. This issue is limited to certain Vivid Ultrasound systems and can result in the incorrect patient information showing on the screen during the exam. If not detected by the operator, images from the actual (intended) patient will be stored under the incorrect patient after the exam. This issue could lead to misdiagnosis. There have been no injuries reported because of this issue.