Known Identifiers & Locations
FEI Numbers
2518422
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (1)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0008-2015 |
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.
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.
|
2014-09-17 |
Terminated
|
View Details
|
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