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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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…"
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…
- Manufacturer
- Respironics California Inc
- Category
- Medical Device — Ventilators
Distribution
Distribution scope not specified by the agency.
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