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Terminated

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

FDA Recall Z-2004-2008 · Posted 2008-09-17

Recalling FirmRespironics California Inc
Recall StatusTerminated
Product CodeCBK
Date Initiated2008-01-25
Date Terminated2012-06-14
Product Quantity309 units

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041412ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000Respironics California, Inc. · 2004-06-18K034040ESPRIT VENTILATOR, MODEL V1000Respironics, Inc. · 2004-01-21K023350ESPRIT VENTILATOR WITH RESPIRATORY MECHANICSRespironics California, Inc. · 2002-11-06K001208ESPIRTRespironics, Inc. · 2000-05-12K981072ESPRIT VENTILATORRespironics, Inc. · 1998-11-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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