Esprit Ventilator, Model Number V1000, Power Supply PN 1015852 and Power Supply Field Replacement Unit (FRU) PN, Continu

FDA device recall Z-0047-2007 · posted 2006-10-19 · Terminated

Recall details

Recalling firm

Respironics California Inc

Reason for recall

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.

Action taken

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 affected component by signing and dating the activity on the Ventilator Field Action Log (reference sample on Appendix IV). The serial number of the power supply destroyed will also be recorded on the log.

Root cause

Other

Status

Terminated

Product code

CBK

Quantity affected

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 Afric

Date initiated

2006-08-08

Date posted

2006-10-19

Date terminated

2010-01-08

Location

Carlsbad, CA

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