Entity profile compiled from public source records
| Recall # | Product Description | Initiation Date | Status | Action |
|---|---|---|---|---|
| Z-0008-2011 | GE Datex-Ohmeda Aisys Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland Reason: Users may inadvertently leave a test plug in the inspiratory flow sensor after completing Low P Leak Check on the SCGO (Switched Common Gas Outlet) configuration of Avance, Amingo, and Aisys anesthesia machines that may impact patient safety. If the test plug remains in place and therapy is initiated, the machine will not provide gas to the patient. This would inhibit mechanical or manual ventila | 2010-08-30 | Terminated | View Details |
| Z-0009-2011 | GE Datex-Ohmeda Avance Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland Reason: Users may inadvertently leave a test plug in the inspiratory flow sensor after completing Low P Leak Check on the SCGO (Switched Common Gas Outlet) configuration of Avance, Amingo, and Aisys anesthesia machines that may impact patient safety. If the test plug remains in place and therapy is initiated, the machine will not provide gas to the patient. This would inhibit mechanical or manual ventila | 2010-08-30 | Terminated | View Details |
| Z-0009-2014 | GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation. Reason: GE Healthcare has recently become aware of a potential safety issue involving the Avance, Avance CS2, and Aisys anesthesia devices. While operating in Pressure Control Ventilation Volume Guarantee (PCV-VG) mode, the affected products may produce an over delivery tidal volume when given a unique sequence of user inputs and a collapsed bellows (partially filled circuit). Exposure to excessiv | 2013-09-16 | Terminated | View Details |
| Z-0010-2011 | GE Datex-Ohmeda Amingo Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland Reason: Users may inadvertently leave a test plug in the inspiratory flow sensor after completing Low P Leak Check on the SCGO (Switched Common Gas Outlet) configuration of Avance, Amingo, and Aisys anesthesia machines that may impact patient safety. If the test plug remains in place and therapy is initiated, the machine will not provide gas to the patient. This would inhibit mechanical or manual ventila | 2010-08-30 | Terminated | View Details |
| Z-0010-2014 | GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume or pressure control ventilation. Reason: GE Healthcare has recently become aware of a potential safety issue involving unresponsive buttons on the display of the Engstrm ventilator and the Aespire View, Aisys, and Avance anesthesia machines. As a result of a manufacturing issue, the buttons on the left, right, and bottom keypads may not always detect button presses. This may result in the inability to access certain menu functions wh | 2013-08-28 | Terminated | View Details |
| Z-0010-2015 | GE Healthcare Precision 500D, Classical R&F System. Product Usage: The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and Pediatric examinations. Reason: GE Healthcare has become aware of a potential safety issue involving missing screws used for mounting the overhead Video Monitor to the tray assembly on a single monitor suspension. This issue affects the Precision 500D X-ray imaging systems. | 2014-09-05 | Terminated | View Details |
| Z-0012-2014 | GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is intended for use in a diagnostic X-ray system to support patients during general purpose radiological procedures in the horizontal, vertical and trendelenburg positions. - The Expedio 500D is designed to perform radiographic and fluoroscopic x-ray examinations. - The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. The Precision 500D R&F X-ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Reason: GE Healthcare has recently become aware of a potential safety issue involving the spotfilm device power assist handle. There is a potential for the internal bolts on the power assist handle to be loose or to loosen and/or fall out. This issue, if present, can result in a loss of calibration and offset of the power assist handle and/or, under extreme condition, sticking of the handle in the ON p | 2013-08-30 | Terminated | View Details |
| Z-0012-2022 | Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system Reason: A software anomaly exists in the Centricity Universal Viewer study management feature in which study changes are not propagated to either the Centricity Enterprise Archive (EA) or another Vendor Neutral Archive (VNA). | 2021-08-12 | Terminated | View Details |
| Z-0021-2014 | GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ. Intended for general purpose diagnostic fluoroscopy and radiography studies. Reason: GE Healthcare has become aware of a potential safety issue involving missing screws in the overhead Video Monitor Suspension of the Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Cardiovascular X-ray imaging systems. | 2013-08-16 | Terminated | View Details |
| Z-0023-2014 | GE, Optima CT660. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data. Reason: GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your scanner which involves Optima CT660, Brivo CT385, Discovery PET/CT 610, Discovery PET/CT 710. The DMPR and Screen Save functionality may possibly generate the same Series UID. It has been seen that some PACS may combine series under a patient using only the Series UID | 2013-03-26 | Terminated | View Details |
| Z-0024-2014 | GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging. Reason: GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your scanner which involves Optima CT660, Brivo CT385, Discovery PET/CT 610, Discovery PET/CT 710. The DMPR and Screen Save functionality may possibly generate the same Series UID. It has been seen that some PACS may combine series under a patient using only the Series UID | 2013-03-26 | Terminated | View Details |
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