Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V1000 and Esprit/V200 Conversion…
Medical device recall Z-0485-2015. Published in FDA’s Enforcement Report on Dec 3, 2014.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 3, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 3,943 units total (3,071 units in US) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
If the power supply fan mounting screws are installed incorrectly, the ends of the screws may touch the power supply printed circuit board assembly (PCBA) and short to ground. This may prevent the ventilator to switch to battery power if AC power is disrupted.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V1000 and Esprit/V200 Conversion Ventilators are microprocessor-controlled, electrically powered mechanical ventilators. Intended for use by medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients.
3,943 units total (3,071 units in US), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
All Esprit V1000 ventilators manufactured prior to December 31, 2004 and those units manufactured prior to 12/2004 that have been converted to V200. Serial Numbers VS3000584 VS3000614 VS3001023 VS3001026 VS3001046 VS3001122 VS3001123…
Every code shown here, 1,994 characters
All Esprit V1000 ventilators manufactured prior to December 31, 2004 and those units manufactured prior to 12/2004 that have been converted to V200. Serial Numbers VS3000584 VS3000614 VS3001023 VS3001026 VS3001046 VS3001122 VS3001123 VS3001643 VS3001814 VS3001815 VS3002027 VS3002079 VS3004925 VS3001953 VS3001979 VS3002122 VS3004232 VS3004312 VS3004336 VS3004342 VS3004348 VS3004946 VS3005661 VS3005779 VS3000536 VS3000538 VS3000542 VS3000927 VS3000935 VS3001253 VS3001255 VS3001314 VS3001355 VS3001388 VS3001986 VS3002078 VS3002625 VS3002737 VS3002768 VS3002804 VS3002832 VS3002835 VS3003127 VS3003194 VS3003199 VS3003218 VS3004609 VS3004841 VS3000570 VS3000638 VS3001007 VS3001017 VS3001027 VS3001110 VS3001222 VS3001256 VS3001266 VS3001313 VS3001501 VS3001502 VS3001503 VS3001504 VS3001505 VS3001507 VS3001508 VS3001509 VS3001514 VS3001515 VS3001653 VS3001694 VS3001748 VS3001766 VS3001781 VS3001786 VS3001795 VS3001797 VS3001799 VS3001804 VS3001808 VS3001809 VS3002016 VS3002662 VS3002749 VS3005907 VS3006181 VS3000604 VS3000675 VS3001276 VS3001366 VS3001768 VS3002199 VS3002205 VS3002823 VS3004607 VS3004642 VS3004684 VS3004685 VS3004723 VS3004803 VS3004832 VS3004916 VS3004945 VS3005626 VS3005797 VS3005852 VS3005865 VS3005902 VS3005984 VS3006200 VS3006218 VS3003252 VS3003301 VS3003343 VS3003427 VS3003672 VS3003673 VS3003674 VS3003742 VS3003746 VS3003787 VS3003817 VS3003829 VS3003833 VS3003913 VS3003933 VS3004565 VS3004648 VS3004689 VS3004729 VS3004830 VS3004942 VS3004956 VS3004974 VS3004983 VS3005041 VS3005627 VS3005656 VS3005665 VS3005681 VS3005689 VS3005690 VS3005702 VS3005719 VS3005731 VS3005752 VS3005778 VS3005789 VS3005800 VS3005801 VS3005802 VS3005806 VS3005811 VS3005813 VS3005814 VS3005815 VS3005819 VS3005823 VS3005824 VS3005828 VS3005834 VS3001865 VS3001981 VS3001982 VS3001990 VS3003696 VS3003219 VS3003876 VS3004563 VS3006204 VS3006212 VS3000576 VS3002176 VS3002223 VS3002678 VS3004555 VS3004785 VS3004798 VS3005695 VS3005784 VS3005909 VS3001691 VS3003214 VS3003272…
FDA’s list runs to 39,591 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Ecuador, Egypt, Greece, Hong Kong, India, Italy, Korea, Lebanon, Malaysia, Mexico, Pakistan, Panama, Peru, Philippines, Saudi Arabia, Singapore, South Africa, Spain, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Vietnam, and Yemen.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Oct 29, 2014.
- FDA classified it on Nov 27, 2014.
- FDA’s Enforcement Report published it on Dec 3, 2014.
- FDA terminated it on Jun 7, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Respironics California Inc, of Carlsbad, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 39,591 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.