Esprit V1000 and V200 Ventilators
Medical device recall Z-0008-2015. Published in FDA’s Enforcement Report on Oct 29, 2014.
- FDA Class I
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 Oct 29, 2014. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 2,206 units total (665 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 I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
A failure of a specific component may prevent the ventilators from operating on AC power or transitioning back to AC power when operating on battery. Additionally, if a battery is not present or is depleted the ventilators will not operate. This failure will cause the loss of ventilator support, which may result in hypercarbia or hypoxemia.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.
2,206 units total (665 units in US), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: VS0002577 VS0002579 VS0002580 VS0002581 VS0002583 VS0002584 VS0002585 VS0002586 VS0002587 VS0002588 VS0002589 VS0002590 VS0002593 VS0002595 VS0002596 VS0002599 VS0002602 VS0002603 VS0002604 VS0002605 VS0002606 VS0002609…
Every code shown here, 1,996 characters
Serial Numbers: VS0002577 VS0002579 VS0002580 VS0002581 VS0002583 VS0002584 VS0002585 VS0002586 VS0002587 VS0002588 VS0002589 VS0002590 VS0002593 VS0002595 VS0002596 VS0002599 VS0002602 VS0002603 VS0002604 VS0002605 VS0002606 VS0002609 VS0002610 VS0002611 VS0002613 VS0002615 VS0002616 VS0002625 VS0002630 VS0002746 VS0002750 VS0002752 VS0002753 VS0002759 VS0002728 VS0002773 VS0002765 VS0002772 VS0002828 VS0002842 VS0002830 VS0002834 VS0002859 VS0002873 VS0002874 VS0002877 VS0002879 VS0002884 VS0002844 VS0002846 VS0002847 VS0002851 VS0002856 VS0002891 VS0002815 VS0002816 VS0002924 VS0002927 VS0002929 VS0002932 VS0002933 VS0002934 VS0002936 VS0002938 VS0002939 VS0002943 VS0002942 VS0002947 VS0002946 VS0002960 VS0002994 VS0002998 VS0002708 VS0002817 VS0002940 VS0002958 VS0002959 VS0002963 VS0003023 VS0003029 VS0003074 VS0003079 VS0003080 VS0003092 VS0003093 VS0003141 VS0003095 VS0003114 VS0003176 VS0003260 VS0003139 VS0003172 VS0003259 VS0003286 VS0003303 VS0003343 VS0003357 VS0003361 VS0003430 VS0003440 VS0003444 VS0003446 VS0003448 VS0003451 VS0003494 VS0003500 VS0003503 VS0003504 VS0003505 VS0003506 VS0003507 VS0003509 VS0003511 VS0003513 VS0003514 VS0003518 VS0003545 VS0003546 VS0003554 VS0003549 VS0003557 VS0003607 VS0003601 VS0003704 VS0003684 VS0003690 VS0003694 VS0003698 VS0003701 VS0003702 VS0003705 VS0003707 VS0003709 VS0003713 VS0003657 VS0003733 VS0003600 VS0003757 VS0003743 VS0003744 VS0003750 VS0003751 VS0003755 VS0003756 VS0003818 VS0003819 VS0003820 VS0003822 VS0003823 VS0003825 VS0003826 VS0003828 VS0003829 VS0003830 VS0003831 VS0003876 VS0003886 VS0003890 VS0003891 VS0003892 VS0003922 VS0003907 VS0003921 VS0003923 VS0003924 VS0003925 VS0003896 VS0003913 VS0003939 VS0003940 VS0003942 VS0003897 VS0003906 VS0003944 VS0003945 VS0003960 VS0003971 VS0003975 VS0003973 VS0004010 VS0004016 VS0004017 VS0003791 VS0003792 VS0003993 VS0004004 VS0004023 VS0004024 VS0004056 VS0004062 VS0004068 VS0004069 VS0004072 VS0004077 VS0004079 VS0004087 VS0004095 VS0004060…
FDA’s list runs to 22,105 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, Argentina, China, Egypt, Ethiopia, Honduras, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Jordan, Libyan Arab Yamahiriya, Malaysia, Mali, Mexico, Myanmar (Burma). Nepal, Nigeria. Pakistan, Peru, Philippines, Serbia, Singapore, South Africa, Sri Lanka, United Republic of Tanzania, Thailand, Vietnam, Zimbabwe, Republic of Korea, and Netherlands.
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Sep 17, 2014.
- FDA classified it on Oct 21, 2014.
- FDA’s Enforcement Report published it on Oct 29, 2014.
- FDA terminated it on Sep 28, 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 22,105 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.