Recall Z-0485-2015 ยท CBK Ventilator, Continuous, Facility Use
Respironics California Inc
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.
| Date | Dec 1, 2014 (initiated Oct 29, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | Philips Healthcare sent an Urgent - Field Safety Notice to all affected consignees to inform them that Respironics is recalling the Esprit V1000 and Esprit/V200 Conversion ventilators because 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. A high urgency audible alarm will sound alerting medical personnel of the loss of power. In the absence of AC power, failure of battery power wi |
| Quantity | 3,943 units total (3,071 units in US) |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Ecuador, Egypt, Greece, Hong Kong, India, Italy, Korea, Lebanon, Malaysia, Mexico, Pakistan, Panama, Peru, Philippines, Saudi Arabia, Singapore, South Africa, Sp |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001208 | ESPIRT Respironics, Inc., May 12, 2000 |
| K023350 | ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS Respironics California, Inc., Nov 6, 2002 |
| K034040 | ESPRIT VENTILATOR, MODEL V1000 Respironics, Inc., Jan 21, 2004 |
| K041412 | ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000 Respironics California, Inc., Jun 18, 2004 |
| K981072 | ESPRIT VENTILATOR Respironics, Inc., Nov 12, 1998 |