Recall Z-0485-2015— Respironics California Inc
Class II · Terminated
Class II FDA medical device recall by Respironics California Inc, initiated 2014-10-29, terminated 2016-06-07. It names 5 FDA 510(k) clearances: K041412, K034040, K023350 and 2 more. 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 ventilator support for adult, pediatric and neonatal patients.. Reason: If the power supply fan mounting screws are installed incorrectly, the ends of the screws may touch the power supply printed circuit board assembly (PCBA) and short to ground. This may prevent the ventilator to switch to battery power if AC power is disrupted..
- Recalling firm
- Respironics California Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-29
- Terminated
- 2016-06-07
- Firm location
- Carlsbad, CA, United States
510(k) clearances named in this recall
5 on FDA's record- K041412 — ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000
- 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 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 ventilator support for adult, pediatric and neonatal patients.
Reason for recall
If the power supply fan mounting screws are installed incorrectly, the ends of the screws may touch the power supply printed circuit board assembly (PCBA) and short to ground. This may prevent the ventilator to switch to battery power if AC power is disrupted.
Data sourced from openFDA. This site is unofficial and independent of the FDA.