Respironics Esprit V1000 Ventilator Recall for Power Supply Defect
Respironics is recalling Esprit V1000 and V200 Conversion Ventilators because incorrect screw installation may cause a short circuit, preventing the switch to battery power during AC outages.
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 is classified as FDA Class II, and the defect poses a risk of harm (loss of ventilation support) without reported injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Respironics California Inc is recalling 3,943 units of Esprit V1000 Ventilators and Esprit/V200 Conversion Ventilators. These are microprocessor-controlled, electrically powered mechanical ventilators intended for use by medical personnel to provide continuous or intermittent ventilator support for adult, pediatric, and neonatal patients.
The recall is due to a defect where power supply fan mounting screws may be installed incorrectly. If this occurs, the ends of the screws may touch the power supply printed circuit board assembly (PCBA) and short to ground. This condition may prevent the ventilator from switching to battery power if AC power is disrupted.
The affected units are all Esprit V1000 ventilators manufactured prior to December 31, 2004, and those units manufactured prior to December 2004 that have been converted to V200. The recall covers 3,071 units in the US and units distributed internationally to numerous countries including Argentina, Australia, Brazil, and Canada. Medical facilities should check their serial numbers against the provided list and contact Respironics for instructions.
The recalled product
- Product
- Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V1000 and Esprit/V200 Conversion Ventilators are microprocessor-controlled, electrically powered mechanical ventilators. Intended for use by medical personnel to provide continuous or intermittent ventila
- Manufacturer
- Respironics California Inc
- Category
- Medical Device — Ventilator
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Esprit V1000 ventilators manufactured prior to December 31
Distribution
Distributed nationwide across the United States.
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- High
- Severe