Recall Z-0008-2015— Respironics California Inc
Class I · Terminated
Class I FDA medical device recall by Respironics California Inc, initiated 2014-09-17, terminated 2016-09-28. It names 4 FDA 510(k) clearances: K034040, K023350, K001208 and 1 more. 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 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..
- Recalling firm
- Respironics California Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2014-09-17
- Terminated
- 2016-09-28
- Firm location
- Carlsbad, CA, United States
510(k) clearances named in this recall
4 on FDA's record- K034040 — ESPRIT VENTILATOR, MODEL V1000
- K023350 — ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS
- K001208 — ESPIRT
- K981072 — ESPRIT VENTILATOR
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.