Recall Z-0047-2007 ยท CBK Ventilator, Continuous, Facility Use
Respironics California Inc
Esprit Ventilator, Model Number V1000, Power Supply PN 1015852 and Power Supply Field Replacement Unit (FRU) PN, Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics 1018246
| Date | Oct 19, 2006 (initiated Aug 8, 2006) |
| Status | Terminated |
| Reason | This action is being initiated due to power supply snubber board failures on certain Esprit Ventilators in countries that utilize operating voltages of 200-240 Volts AC and will involve the replacement of the Esprit Ventilator power supply snubber board. Returned power supplies have shown evidence of overheating and in some cases in which a fan also failed, have shown signs of fire damage. |
| Root cause | Other |
| Action | The field action will be conducted through consignees (distributors) in the affected countries. The distributors were notified of the field action by Federal Express au on August 8th, 2006. The distributors have been informed that Respironics will provide replacement circuit boards at no cost and will be instructed to upgrade the ventilator power supplies in their region. Instructions have been provided to the distributors and users on how to evaluate the ventilator to be able to continue to use it pending the completion of the upgrades. The distributors will document the replacement of the a |
| Quantity | 950 |
| Distribution | Worldwide, including Algeria, Argentina, Australia, Bangladesh, Brazil, Cambodia, Chile, Egypt, France, Hong Kong, India, Italy, Jordan, Lebanon, Malaysia, Pakistan, Peru, Philippines, Russia, S Africa, S Korea, Spain, Thailand, Turkey, United Kingdon, & Vietnam |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981072 | ESPRIT VENTILATOR Respironics, Inc., Nov 12, 1998 |