Recall Z-0008-2015 ยท CBK Ventilator, Continuous, Facility Use
Respironics California Inc
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.
| Date | Oct 21, 2014 (initiated Sep 17, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Unknown/Undetermined by firm |
| Action | Philips Healthcare sent an Urgent - Field Safety Notice dated September 17, 2014, to all customers who purchased the Esprit V1000 and V200 Ventilators to inform them that Respironics is recalling Esprit V1000 and V200 Ventilators installed with 3rd Generation Power Supplies and also 3rd Generation Power Supply Repair Part Kits. The letter identifies the affected devices, informs the customers of the problems, hazard involved, and the actions to be taken. Customers were reminded to be advised of the warnings provided. A Philips Respironics representative will contact customers to schedule a |
| Quantity | 2,206 units total (665 units in US) |
| Distribution | 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 Repu |
| FDA record | Open on fda.gov |