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GE Healthcare 13 articles

GE Healthcare recalls Infant Warming Systems due to potential safety hazard

Screws from the heater head of some GE Healthcare Infant Warming Systems used to provide warmth to newborns at medical facilities have come loose and fallen onto the bed of the product, causing injuries in at least two babies. As a result, GE Healthcare is recalling certain models and making health care professionals who work in labor and delivery departments and neonatal intensive care units aware of this potential safety hazard and the risk of thermal injuries to patients. GE Healthcare’s Infant Warmer Systems provide varying thermoregulation for infants. They provide radiant heat over bassinets in nurseries, complete thermoregulation in the ... Read More

FDA issues injury warning about MRI units

The Food and Drug Administration (FDA) is warning health care professionals that some MRI units may have been modified to disable the Magnet Rundown Unit (MRU), which is one method to shut off the magnet field of the MRI in case of emergency, such as when a metal (ferrous) object is brought into the magnet field. In the event of an emergency, a delay in shut off can result in life-threatening injuries. At least two hospital employees have been injured when they entered the MRI room carrying a metal container. The recall is being issued because this defect may cause ... Read More

Hospital CO2 detector accessories recalled due to life threatening defect

GE Healthcare is recalling accessories for its CO2 detectors because they may cause the device to fail or to provide incorrect CO2 values for mechanically and spontaneous ventilated patients. Physicians rely on these devices to make decisions, and if those decisions are based on incorrect readings from these machines, permanent, irreversible impairment or life threatening changes could occur in patients, such as inadequate exchange of gasses (hypoventilation), causing an increased concentration of CO2 (hypercapnia), which can be deadly. The recall involves GE Healthcare single-width airway modules (E-MiniC) and accessories and Extension Modules (N-FC, N-FCREC). It is classified as a Class ... Read More

GE Healthcare recalls newborn resuscitator systems

GE Healthcare is ordering a recall of some of its resuscitation systems designed to deliver oxygen to newborns. The recall is due to a manufacturing error that may interfere with oxygen delivery and may lead to low blood oxygen (hypoxia) or high blood oxygen (hyperoxia). These are potentially deadly conditions for newborns, especially those who are critically ill and/or were born preterm or low birthweight. The recall involves specific lot numbers of the following GE Healthcare products: Giraffe Warmer with Resuscitation System, Panda Warmer with Resuscitation System, Giraffe Stand-Alone Infant Resuscitation System, Resuscitation System Upgrade Kits, and Panda Freestanding with ... Read More

GE Healthcare issues corrective action for defective anesthesia delivery system

GE Healthcare has issued a field corrective action for the Avance, Aisys and Avance CS2 anesthesia delivery systems due to a potential safety issue. Apparently, a unique sequence of inputs and a collapsed bellow could result in delivery of higher-than-expected tidal volume when using the Pressure Control Ventilation – Volume Guarantee mode. All safety over-pressure controls and alarms will continue to function properly; however, over delivery of tidal volume may result in altercations to blood flow within the thorax that, under extreme circumstances, could result in gradual reductions in blood pressure. To date, GE Healthcare has received no reports of ... Read More

Patient death leads to recall of nuclear imaging system

GE Healthcare is recalling several of its Nuclear Medicine Systems after a patient at a VA Medical Center died from injuries received while being scanned by an Infinia Hawkeye 4 Nuclear Medicine System. GE Healthcare acknowledged that serious injuries or deaths could occur due to the failure mode associated with this recall. In nuclear medicine imaging, radiopharmaceuticals are taken internally, either intravenously or orally. Then, external detectors capture and form images from the radiation emitted by the radiopharmaceuticals. Nuclear Medicine Systems are used to perform general nuclear medicine imaging procedures to detect radioisotope tracer absorption in the patient’s body, using ... Read More

Newborn incubators, warmers recalled due to dangerous defect

Some GE Healthcare newborn incubators and warmers are being recalled because of a defect that can case the device to malfunction, thus endangering the lives of infants. The recall involves the Giraffe OmniBed and Giraffe Incubator. The Giraffe OmniBed can function as both an incubator (closed mode) and as a warmer (open mode). Incubators and warmers are used to maintain the body temperature of a newborn baby. In “closed mode,” the OmniBed provides heat through a closed, temperature-controlled environment. In “open mode,” the device provides heat in an open environment using overhead heaters. The Giraffe Incubator is an infant incubator ... Read More

Infant resuscitation systems recalled due to dangerous defect

Resuscitation systems used for the pulmonary resuscitation of infants are being recalled because of a defect that causes them not to provide adequate resuscitation during ventilation. This recall is classified as a Class 1, the most serious type of recall the Food and Drug Administration (FDA) gives and is reserved for products in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death. The recall affects certain models of the GE Healthcare T-Piece Neonatal Patient Circuits for Giraffe and Panda Resuscitation Systems, with size 1 and size 0 masks. The recall ... Read More

Gadolinium federal lawsuits move ahead

Injecting a toxic liquid metal such as gadolinium into the bloodstream may seem like a procedure from a sci-fi horror movie, but it is a common, every day occurrence in medical centers throughout the country. When gadolinium is in the bloodstream, medical imaging devices produce clearer, more defined images of the patient’s blood vessels. Since gadolinium is extremely toxic to human tissue, it must first be coated with a benign chemical before being injected into the patient. Over the course of time, the body expels the metal through the kidneys. Patients with poor kidneys, however, experience a buildup of the toxic ... Read More

Some kidney patients suffer MRI poisoning

A growing number of people are becoming afflicted with an incurable, man-made disease that is related to a common medical procedure performed every single day in this country, a KCRA 3 investigation has found. Sarah Fracella is one the victims. The 38-year-old Santa Barbara resident said what happened to her is “devastating.” The issue involves magnetic resonance imaging scans that include the use of a contrast dye containing gadolinium. For people with healthy, functioning kidneys, the risk of using the element gadolinium to pinpoint potential health problems in MRI scans is zero. “Gadolinium is extremely safe,” said neuroradiologist David Seidenwurm ... Read More