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U.S. Department of Health and Human Services

Class 2 Device Recall Esprit Power Supply Field Replacement

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  Class 2 Device Recall Esprit Power Supply Field Replacement see related information
Date Initiated by Firm January 25, 2008
Date Posted September 17, 2008
Recall Status1 Terminated 3 on June 14, 2012
Recall Number Z-2004-2008
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 Field Replacement Unit (FRU), PN 101 8246
The Esprit Ventilator is a microprocessor controlled, electrically powered, mechanical ventilator.
Code Information PN 1018246; Serial Numbers: VSF5200298 VSF5200306 VSF5200312 VSF5200337 VSF5200398 VSF5200466 VSF5200628 VSF5200571 VSF5200608 VSF5200615 VSF5200329 VSF5200470 VSF5200474 VSF5200524 VSF5201550 VSF5201552 VSF5202104 VSF5202115 VSF5202826 VSF5202829 VSF5201193 VSF5201199 VSF5201202 VSF5201203 VSF5201204 VSF5202791 VSF5202793 VSF5200224 VSF5200292 VSF5200350 VSF5200351 VSF5203007 VSF5203118 VSF5203226 VSF5203704 VSF5203732 VSF5204192 VSF5204201 VSF5204209 VSF5204212 VSF5200297 VSF5200406 VSF5200340 VSF5200065 VSF5200067 VSF5200080 VSF5201108 VSF5204331 VSF5204335 VSF5204359 VSF5201082 VSF5201094 VSF5200089 VSF5200310 VSF5203769 VSF5203847 VSF5200326 VSF5201746 VSF5200303 VSF5200809 VSF5201557 VSF5200407 VSF5200551 VSF5200555 VSF5200567 VSF5200631 VSF5200638 VSF5200645 VSF5200793 VSF5200802 VSF5200824 VSF5200827 VSF5200846 VSF5203473 VSF5203622 VSF5203846 VSF5204323 VSF5203470 VSF5202787 VSF5203216 VSF5203227 VSF5203229 VSF5203232 VSF5203110 VSF5204060 VSF5204061 VSF5204068 VSF5204175 VSF5204154 VSF5200348 VSF5200359 VSF5200364 VSF5200400 VSF5200404 VSF5202388 VSF5203708 VSF5204156 VSF5203678 VSF5200357 VSF5200360 VSF5200374 VSF5200378 VSF5200388 VSF5200412 VSF5200476 VSF5200481 VSF5200508 VSF5200527 VSF5200531 VSF5200532 VSF5200533 VSF5204180 VSF5204262 VSF5204365 VSF5204367 VSF5204439 VSF5204444 VSF5204447 VSF5204451 VSF5204461 VSF5204465 VSF5204466 VSF5204467 VSF5204468 VSF5204512 VSF5204516 VSF5204517 VSF5204520 VSF5204529 VSF5201595 VSF5201710 VSF5201974 VSF5202819 VSF5202830 VSF5204437 VSF5204492 VSF5203161 VSF5203420 VSF5203810 VSF5203848 VSF5203174 VSF5203411 VSF5203677 VSF5203439 VSF5200096 VSF5200098 VSF5200100 VSF5200101 VSF5200102 VSF5200103 VSF5200104 VSF5200105 VSF5200106 VSF5200107 VSF5200108 VSF5200110 VSF5200111 VSF5200112 VSF5200114 VSF5200115 VSF5200116 VSF5200118 VSF5200119 VSF5200121 VSF5200122 VSF5200347 VSF5200855 VSF5201026 VSF5201163 VSF5201175 VSF5201505 VSF5201522 VSF5201523 VSF5201545 VSF5201547 VSF5201750 VSF5201758 VSF5202057 VSF5202116 VSF5202125 VSF5202395 VSF5203027 VSF5203426 VSF5203725 VSF5203772 VSF5203849 VSF5204063 VSF5204093 VSF5204128 VSF5204138 VSF5204141 VSF5204145 VSF5204194 VSF5204200 VSF5204307 VSF5204315 VSF5204452 VSF5204477 VSF5204482 VSF5204486 VSF5204489 VSF5204490 VSF5204519 VSF5200097 VSF5200259 VSF5200284 VSF5200377 VSF5200550 VSF5200862 VSF5200886 VSF5201002 VSF5201013 VSF5201024 VSF5201043 VSF5201044 VSF5201059 VSF5201062 VSF5201078 VSF5201153 VSF5201167 VSF5203855 VSF5204050 VSF5204178 VSF5204254 VSF5200113 VSF5200099 VSF5200109 VSF5200281 VSF5200386 VSF5200462 VSF5200480 VSF5200528 VSF5200573 VSF5200586 VSF5200831 VSF5200843 VSF5200844 VSF5200895 VSF5201011 VSF5201020 VSF5201050 VSF5201029 VSF5201063 VSF5201067 VSF5201138 VSF5201161 VSF5201168 VSF5201169 VSF5201178 VSF5201192 VSF5201158 VSF5201181 VSF5201182 VSF5201751 VSF5201997 VSF5202238 VSF5202252 VSF5202248 VSF5202255 VSF5203024 VSF5203025 VSF5203028 VSF5203179 VSF5203753 VSF5203858 VSF5204028 VSF5204179 VSF5204142 VSF5204150 VSF5204041 VSF5204252 VSF5204313 VSF5204326 VSF5203105 VSF5203422 VSF5201244 VSF5201569 VSF5202394 VSF5201240 VSF5201257 VSF5201504 VSF5202096 VSF5203047 VSF5203173 VSF5203233 VSF5203475 VSF5201510 VSF5202798 VSF5203006 VSF5203053 VSF5203183 VSF5203432 VSF5204158 VSF5204266 VSF5204357 VSF5204387 VSF5204392 VSF5204337 VSF5201260 VSF5201268 VSF5202055 VSF5203184 VSF5202124 VSF5202005 VSF5204364 VSF5204370 VSF5203987 VSF5204518 and  VSF5200343 
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 2		 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 309 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.
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