Home / Recalls / Medical Devices
Respironics California Inc recalls Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits
Recalled October 29, 2014 · FDA recall Z-0008-2015 · Respironics California
Hazard
A failure of a specific component may prevent the ventilators from operating on AC power or transitioning back to AC power when operating on battery. Additionally, if a battery is not present or is depleted the ventilators will not operate. This failure will cause the loss of ventilator support, which may result in hypercarbia or hypoxemia. · FDA Class I
Units
2,206 units total (665 units in US)
Sold at
Worldwide Distribution - USA, Argentina, China, Egypt, Ethiopia, Honduras, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Jordan, Libyan Arab Yamahiriya, Malaysia, Mali, Mexico, Myanmar (Burma). Nepal, Nigeria. Pakistan, Peru, Philippines, Serbia, Singapore, South Africa, Sri Lanka, United Republic of Tanzania, Thailand, Vietnam, Zimbabwe, Republic of Korea, and Netherlands.
Description
A failure of a specific component may prevent the ventilators from operating on AC power or transitioning back to AC power when operating on battery. Additionally, if a battery is not present or is depleted the ventilators will not operate. This failure will cause the loss of ventilator support, which may result in hypercarbia or hypoxemia.
Product
Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.
Manufacturer(s)
Respironics California Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →