GE Healthcare Recalls

Hazard: GE Healthcare has recently become aware of a potential safety issue with respect to the automated PERCIST response criteria calculation applied in the PET VCAR application on Advantage Workstation or AW Server.

Hazard: GE Healthcare has recently become aware of a potential safety issue involving the reusable CO2 absorbent canister accessory used with Aespire, Aespire View, Avance, Avance CS2, Aisys, ADU, 9100, M900, M904, 9300 systems. Reusable CO2 absorbent canisters accessories may not seal properly.

Hazard: While performing a fluoroscopic examination on the GE Innova systems, there is a potential of nonrecoverable loss of imaging modes with no advance warning, due to a relay failure in the power distribution box (PDB). Although no injuries have been reported due to this issue to date, there is risk of complications during the procedure as a result of imaging functionality loss.

Hazard: Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.

Hazard: Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.

Hazard: GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. The axial and coronal reformatted images from a sagittal 3D series (such as with applications of FSPGR-3D T1, BRAVO T1, or CUBE T1) of over 126 slices may display a left-to-right image flip . In addition, the acquired sagittal images may be annotated with left-right location annotation revers

Hazard: GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. The axial and coronal reformatted images from a sagittal 3D series (such as with applications of FSPGR-3D T1, BRAVO T1, or CUBE T1) of over 126 slices may display a left-to-right image flip . In addition, the acquired sagittal images may be annotated with left-right location annotation revers

Hazard: GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. The axial and coronal reformatted images from a sagittal 3D series (such as with applications of FSPGR-3D T1, BRAVO T1, or CUBE T1) of over 126 slices may display a left-to-right image flip . In addition, the acquired sagittal images may be annotated with left-right location annotation revers

Hazard: Fastener bolts on the heat exchanger were not properly torqued and part of the heat exchanger can detach from the gantry and hit the inside of the covers and other components of the gantry possibly resulting in the oil conduit breaking, spilling oil within the gantry and outside the system. This issue affects GE Healthcare VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspe

Hazard: GE Healthcare has recently become aware of an incident which caused a patient injury during an unload following an exam on a Ventri scanner. During a patient unload following a scan, the patients fingers may be pinched between the moving cradle edge and the stationary base of the table while the table is moving outward automatically.

Hazard: GE Healthcare has become aware of a software issue in your Xeleris 2.1 workstation (that is used for processing Discovery 530/570 data), that may impact patient safety. On imported CT scans, Myocardial Perfusion Imaging (MPI) studies may create artifacts in attenuation corrected images. This may lead to a potential for misdiagnosis.

Hazard: As part of GE Innova IQ table introduction, a label was designed to be affixed on the front Cover of the Gantry Pivot section. This safety label is missing on systems manufactured between March 2010 and July 2011. In the situation a staff member (doctor, nurse, operator, anesthetist, etc&) stands in the region between the C-arm gantry pivot and the head section of the table, there is a risk of co

Hazard: GE Healthcare has recently become aware of a potential safety issue with respect to the Results Viewer in the AW Server. After starting the Results Viewer with the selected series of a patient, the pixel and certain annotation data from a different patient is displayed in one of the viewports. This occurs on an occasional basis, when multiple users are simultaneously accessing the Results Viewe

Hazard: GE Healthcare conducted a recall on the Muse v7 because incorrect medications were displayed on the MUSE, which could result in incorrect treatment.

Hazard: GE Healthcare has recently become aware of a potential issue due to image flip in frequency encoding direction associated with a specific workflow of your Discovery MR750w system. Image flip issue in frequency encoding direction (including S/I, A/P and R/L) can result in incorrect localization of anatomy and pathological findings.

Hazard: GE Healthcare has become aware of a potential safety issue due to the S4-10-D Ultrasound Probe used in conjunction with the LOGIQ S8 and LOGIQ S7 Ultrasound systems. It was also discovered that this issue also leads to a specification issue of the acoustic output of this probe. There is a potential for a skin burn when the flow model in the cardiac application is activated with the S4-10-D Ultraso

Hazard: GE Healthcare has become aware of an issue associated with the base casting for the articulated arm of your VMX and VMX Plus Mobile X-ray systems that may impact Operator or Patient safety.

Hazard: Accelerated fatigue of the lateral axis motion subsystem of the Infinia Computed Emission Tomography System could result in mechanical failure causing the detector to slide; may impact patient and operators.

Hazard: Neonatal beds and incubator display boards may randomly overwrite stored information and radiant heater and oxygen set points upon power up or recovery from a power failure.

Hazard: A locking nut might loosen out of the overhead Video Monitor Suspension yoke affecting Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, and Innova 4100IQ Cardiovascular X-ray imaging systems.

Hazard: An error on the SR Viewer Reporting Tool in which edits can be made on a report and can be saved into incorrect reports.

Hazard: Exposed high voltage wires inside the cabinet . On a cable located in the system cabinet, two of the shrink tubings covering the 400V live cable leave an area potentially unprotected.

Hazard: Incorrect views and measurements possible. GE Healthcare became aware of multiple potential safety issues involving the Advantage workstation, Volume Viewer Plus and Volume Analysis.

Hazard: GE Healthcare has become aware of a software issue on the interface of the Brivo XR385 DR-F/ Model 5271997 radiographic product related to Visual indication as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-1-3.

Hazard: When quickly switching the protocols from AEC to Fixed under the same view, if the user selection process time is less than 0.5 seconds, the User Interface (UI) may display different exposure techniques than selected, and may not display AEC setting. The exposure can still be made as commanded, however it may not be properly indicated.

Hazard: When quickly switching the protocols from AEC to Fixed under the same view, if the user selection process time is less than 0.5 seconds, the User Interface (UI) may display different exposure techniques than selected, and may not display AEC setting. The exposure can still be made as commanded, however it may not be properly indicated.

Hazard: GE Healthcare has become aware of potential issues associated with the CARESCAPE Monitor B650. There have been no reported illnesses or injuries that have occurred with the use of the device.

Hazard: GE has become aware of multiple issues affecting the Dash 3000/4000/5000 and DashPort 2 monitor. This report of correction encompasses the DashPort 2 device, in which the DashPort 2 stops communicating with the Dash, resulting in Loss of Monitoring at the CIC. The DashPort 2 status LEDs in the back of the unit indicate Unity Network and DashPort 2 to Dash communication has stopped.

Hazard: GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor. These issues may occur when the Ethernet controller in the XPC823 CPU on the Dash and DashPort 2 motherboard functions intermittently. GE Healthcare has identified that these issues occur most often at sites with large Unity Network installations. It should be noted that the Dash 3000/4000/5000 patient m

Hazard: Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.