Esprit Ventilator, Model V1000 manufactured with Power Supply PN 1015852 The Esprit Ventilator is a microprocessor contr

FDA device recall Z-2002-2008 · posted 2008-09-17 · Terminated

Recall details

Recalling firm

Respironics California Inc

Reason for recall

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.

Action taken

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 Ventilators and FRUs in each distributors respective region. Contact Respironics California, Inc. at 1-760-918-7328 for assistance.

Root cause

Device Design

Status

Terminated

Product code

CBK

Quantity affected

1,462 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, Singapo

Date initiated

2008-01-25

Date posted

2008-09-17

Date terminated

2012-06-14

Location

Carlsbad, CA

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