Recall Z-2004-2008 ยท CBK Ventilator, Continuous, Facility Use
Respironics California Inc
Esprit Power Supply Field Replacement Unit (FRU), PN 101 8246 The Esprit Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator.
| Date | Sep 17, 2008 (initiated Jan 25, 2008) |
| Status | Terminated |
| Reason | This action is being taken to address power supply failures on the Esprit Ventilator which have occurred in some units. These failures, which were discovered through routine product monitoring, have been reported in countries that utilize an input voltage of greater than 200 volts AC. Some customers have reported a burning smell coming from the ventilator. |
| Root cause | Device Design |
| Action | On January 25, 2008, letters were sent to all existing Esprit distributors in > 200 volt countries. This letter notified customers of the pending field action, the reason for the action and included a set of instructions that end users need to follow in order to be able to continue using their Esprit pending the installation of replacement parts. The letter also stated that as soon as replacement parts are available, customers will be provided with a serial number list of their affected units. Respironics will provide replacement parts at no cost and instructions to upgrade the Esprit Ventilat |
| Quantity | 309 units |
| Distribution | Internationally to: Argentina, Turkey, Peru, Russia, Uruguay, Malaysia, Lebanon, India, Spain, Hong Kong, Brazil, UAE, Cambodia, Thailand, Chile, Philippines, South Korea, Vietnam, Bangladesh, Singapore, Italy, United kingdom, South Africa, Egypt, Pakistan, Jordan, Algeria, and Japan |
| 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 |