WASHINGTON, D.C. — General Electric’s Healthcare division announced an urgent recall for certain respiratory analyzer devices. The U.S. Food and Drug Administration, better known as the FDA, graded GE Healthcare’s recall program as a Class I recall. The FDA reserves Class I recalls for devices or medication that could pose an immediate threat to the safety of the patient and is the most serious recall designation employed by the FDA according to MassDevice.com. GE Healthcare did not say how it proposes to repair the problem that necessitated the recall. To this point, GE Healthcare and the FDA said that there had been no reports of injuries or fatalities caused by the failing devices.
GE Healthcare announced it would recall several respiratory analyzers because of faulty sensors. The defective oxygen sensors used in GE Healthcare’s Carescape modules and Air Gas Option NCAiO units forced GE Healthcare to announce the recall. The FDA explained that the faulty oxygen sensors could result in inaccurate oxygen saturation readings. The defects causing inaccurate readings could lead to significant health problems including increased risk of death, infection, tissue injury, and irreparable organ damage.
Healthcare providers such as hospitals, clinics, and doctors’ offices must be aware of which machines GE Healthcare recalled. GE Healthcare’s sweeping recall initiative of eight models includes the Carescape B850, B650, B450, B40(i), B105, and B125 patient monitors. The recall encompasses GE Healthcare’s Avance CS2, Aisys CS2, 620, 650, and 650c anesthesia Carestations. Furthermore, the Carescape critical care ventilator R860, along with the S/5 modular monitors, are subject to the recall announced by GE Healthcare.
GE Healthcare’s Airway Gas Option, which is compatible with the B40(i), B105, B125 monitors and Carestations 620, 650, and 650c anesthesia monitors, are also subject to the recall program.
Despite GE Healthcare’s claims that patient safety is the foremost priority, this recall is the second recall announced by GE Healthcare in as many weeks.