The Recall Desk
HighFDA (Devices)·Z-0008-2015·Announced 2014-10-29

Respironics Esprit Ventilators Recalled for Power Supply Failure Risk

Respironics is recalling Esprit V1000 and V200 ventilators because a power supply failure may cause loss of ventilator support, potentially leading to hypercarbia or hypoxemia.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where a power failure may result in loss of ventilator support, causing hypercarbia or hypoxemia. This fits the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Respironics California Inc is recalling 2,206 Esprit V1000 and V200 Ventilators, including 665 units in the United States. The recall also covers the 3rd Generation Power Supply Repair Part (RP) Kits. These microprocessor-controlled, electrically powered mechanical ventilators are intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric, and neonatal patients.

The recall is due to a failure of a specific component that 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.

The affected units were distributed worldwide, including in the 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. Users should check their serial numbers against the list provided in the official recall notice and contact Respironics for instructions on corrective action.

The recalled product

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 ve

Distribution

Distribution scope not specified by the agency.