FDA Recall Terminated

Esprit Power Supply Field Replacement Unit (FRU), PN 101 8246 The Esprit Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator.

Recall: Z-2004-2008 · Initiated January 25, 2008

Recall

Recall Number
Z-2004-2008
Event Number
46818
Firm
Respironics California Inc
FEI Number
2518422
Product Code
CBK
Status
Terminated
Root Cause
Device Design
Initiated
January 25, 2008
Posted
September 17, 2008
Terminated
June 14, 2012
Address
2271 Cosmos Ct, Carlsbad, CA, 92009-1517

Description

Esprit Power Supply Field Replacement Unit (FRU), PN 101 8246 The Esprit Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator.

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.

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

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

Quantity

309 units