Class 2 Device Recall Esprit Power Supply Snubber Board Assembly

• Date Initiated by Firm: January 25, 2008
• Date Posted: September 17, 2008
• Recall Status: Terminated on June 14, 2012
• Recall Number: Z-2003-2008
• Recall Event ID: 46818
• 510(K)Number: K981072 K001208 K023350 K034040 K041412
• Product Classification: Ventilator, Continuous, Facility Use - Product Code CBK
• Product: Esprit Power Supply Snubber Board Assembly FRU, PN 1036236; The Esprit Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator.
• Code Information: PN 1036236; Serial Numbers: VS6500009 VS6500013 VS6500019 VS6500024 VS6500096 VS6500112 VS6500116 VS6500117 VS6500640 VS6500644 VS6500645 VS6500350 VS6500204 VS6500210 VS6500221 VS6500227 VS6500427 VS6500438 VS6500446 VS6500313 VS6500332 VS6500967 VS6500308 VS6500357 VS6500362 VS6500367 VS6500213 VS6500038 VS6500103 VS6500106 VS6500108 VS6500123 VS6500144 VS6500165 VS6500300 VS6500307 VS6500310 VS6500323 VS6500343 VS6500355 VS6500358 VS6500354 F21380F023872 F21380F023873 F21380F023874 F21380F023877 F21380F023878 F21380F023981 F21380F024067 VS6500183 VS6500043 VS6500100 VS6500145 VS6500435 VS6500451 VS6500455 VS6500457 VS6500466 VS6500467 VS6500471 VS6500483 VS6500503 VS6500508 VS6500510 VS6500512 VS6500519 VS6500528 VS6500533 VS6500541 VS6500548 VS6500037 VS6500092 VS6500111 VS6500122 VS6500129 VS6500447 VS6500535 VS6500522 VS6500551 VS6500074 F21380F023825 F21380F023836 F21380F023840 F21380F023844 F21380F023895 F21380F023896 F21380F023905 F21380F023906 F21380F023908 F21380F023912 F21380F023918 F21380F023923 F21380F023924 F21380F023927 F21380F023979 F21380F023987 F21380F024020 VS6500136 VS6500296 VS6500301 VS6500315 VS6500331 VS6500335 VS6500345 VS6500314 VS6500318 VS6500328 VS6500336 VS6500344 VS6500218 VS6500217 VS6500386 VS6500424 VS6500449 VS6500453 VS6500454 VS6500456 VS6500093 VS6500151 VS6500086 VS6500207 VS6500079 VS6500237 VS6500239 VS6500283 VS6500284 VS6500285 VS6500286 VS6500287 VS6500288 VS6500290 VS6500292 VS6500293 VS6500295 VS6500351 VS6500353 VS6500356 VS6500363 VS6500368 VS6500378 VS6500413 VS6500423 VS6500641 VS6500672 VS6500683 VS6500703 VS6500723 VS6500734 VS6500738 VS6500773 VS6500785 VS6500787 VS6500790 VS6500810 VS6500826 VS6500833 VS6500837 VS6500846 VS6500847 VS6500852 VS6500857 VS6500858 VS6500864 VS6500875 VS6500880 VS6500881 VS6500882 VS6500883 VS6500885 VS6500888 VS6500889 VS6500891 VS6500893 VS6500896 VS6500897 VS6500898 VS6500899 VS6500900 VS6500902 VS6500903 VS6500904 VS6500907 VS6500908 VS6500909 VS6500910 VS6500911 VS6500912 VS6500913 VS6500914 VS6500915 VS6500918 VS6500919 VS6500920 VS6500921 VS6500924 VS6500927 VS6500931 VS6500935 VS6500936 VS6500937 VS6500573 VS6500765 VS6500922 VS6500379 VS6500387 VS6500390 VS6500392 VS6500394 VS6500395 VS6500396 VS6500399 VS6500441 VS6500445 VS6500448 VS6500035 VS6500063 VS6500068 VS6500078 VS6500107 VS6500604 VS6500610 VS6500611 VS6500618 VS6500623 VS6500624 VS6500654 VS6500598 VS6500600 VS6500608 VS6500609 VS6500025 VS6500156 VS6500164 VS6500203 VS6500208 VS6500209 VS6500219 VS6500222 VS6500186 VS6500977 VS6500205 VS6500001 VS6500071 VS6500152 VS6500197 VS6500161 VS6500173 and VS6500184
• Recalling Firm/ Manufacturer: Respironics California Inc; 2271 Cosmos Ct; Carlsbad CA 92009-1517
• For Additional Information Contact: Mary Funk; 760-918-7328
• Manufacturer 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.
• FDA Determined Cause: Device Design
• 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.
• Quantity in Commerce: 248 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, Singapore, Italy, United kingdom, South Africa, Egypt, Pakistan, Jordan, Algeria, and Japan
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CBK and Original Applicant = RESPIRONICS CALIFORNIA, INC.; 510(K)s with Product Code = CBK and Original Applicant = RESPIRONICS, INC.