product is a component of the Newport Medical Instruments recalled

Timeline

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Reports of the audible alarm not sounding when the ventilator is in an alarm state. The ventilator, as well as the visual and remote alarms, continue to operate normally.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Recalled product is a component of the Newport Medical Instruments e360 Ventilator: single board computer, part number SBC2105A. Intended to provide invasive or noninvasive ventilator support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency.

Where it was distributed

Worldwide Distribution -- USA, including the states of Arizona, California, Colorado, Connecticut, Florida, Georgia, Kentucky, Massachusetts, Maryland, Missouri, Nevada, Pennsylvania, Rhode Island, Texas, Virginia, and Washington; and, the countries of Algeria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Chile, China, Colombia, Dominican Republic, Ecuador, Egypt, England, France, Germany, Greece, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Japan, Kazakhstan, Kenya, Lebanon, Liechtenstein, Lithuania, Mexico, Morocco, Namibia, Nepal, Netherlands, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Republic of Armenia, Republic of KOS, Russia, Saudi Arabia, Singapore, Slovenia, S. Africa, Sri Lanka, Taiwan, Thailand, Tunisia, Turkey, UAE, Uruguay, Vietnam, and Yemen.

ArizonaCaliforniaColoradoConnecticutFloridaGeorgiaKentuckyMassachusettsMarylandMissouriNevadaPennsylvaniaRhode IslandTexasVirginiaWashington