V60 Ventilator, Continuous Ventilator
Medical device recall Z-2260-2012. Published in FDA’s Enforcement Report on Sep 12, 2012.
- 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 Sep 12, 2012. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 197 units total (116 in the 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?
Respironics is recalling the V60 ventilator because certain blower motor assemblies in the V60 ventilators may not meet specifications. Specifically, the impeller may not be properly seated on the blower motor shaft. This could subsequently cause the blower to cease functioning which would result in the failure of the V60 ventilator to deliver therapy to the patient due to the loss of ventilatio
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490 Product Usage: The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The V60 Ventilator is intended to support pediatric patients weighing 20kg (44 Ibs) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. It is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists.
197 units total (116 in the US), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Seria Numbers: 100026615 100029321 100029838 100030462 100030832 100026808 100029324 100029841 100030463 100030833 100026826 100029325 100029843 100030464 100030834 100027107 100029327 100029845 100030466 100030836 100027181 100029328…
Every code shown here, 1,984 characters
Seria Numbers: 100026615 100029321 100029838 100030462 100030832 100026808 100029324 100029841 100030463 100030833 100026826 100029325 100029843 100030464 100030834 100027107 100029327 100029845 100030466 100030836 100027181 100029328 100029847 100030468 100030838 100027189 100029330 100030043 100030469 100030840 100027544 100029334 100030106 100030471 100030843 100027660 100029337 100030107 100030472 100030844 100027751 100029455 100030111 100030473 100030845 100027870 100029456 100030112 100030474 100030847 100027872 100029459 100030113 100030475 100030850 100027875 100029462 100030115 100030481 100030977 100028047 100029473 100030117 100030482 100030979 100028053 100029474 100030118 100030485 100030980 100028069 100029500 100030119 100030591 100030983 100028249 100029504 100030120 100030593 100030985 100028324 100029505 100030121 100030594 100030986 100028328 100029507 100030133 100030595 100030987 100028334 100029508 100030204 100030596 100030989 100028339 100029512 100030212 100030608 100030990 100028570 100029514 100030215 100030609 100030991 100028665 100029515 100030216 100030612 100030992 100028666 100029516 100030217 100030618 100030994 100028673 100029518 100030220 100030620 100030995 100029074 100029520 100030223 100030762 100030996 100029116 100029524 100030224 100030766 100030997 100029119 100029525 100030226 100030767 100030998 100029215 100029672 100030229 100030768 100031004 100029217 100029679 100030337 100030769 100031071 100029220 100029684 100030342 100030771 100031072 100029223 100029685 100030343 100030773 100031084 100029224 100029690 100030344 100030778 100031085 100029241 100029691 100030345 100030779 100031089 100029242 100029692 100030349 100030780 100031143 100029243 100029698 100030355 100030781 100031144 100029313 100029832 100030359 100030782 100031147 100029316 100029833 100030456 100030823 201002392 100029318 100029835 100030457 100030825 100029319 100029836 100030458 100030827 100029320 100029837 100030459 100030829
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 - US (Nationwide) and the countries of: Australia, Belgium, Canada, China, Germany, Italy, Japan, Kuwait, Netherlands, Norway. Qatar, Saudi Arabia, Turkey, and United Kingdom.
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 Jul 31, 2012.
- FDA classified it on Aug 31, 2012.
- FDA’s Enforcement Report published it on Sep 12, 2012.
- FDA terminated it on Mar 22, 2013.
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.”
- 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
-
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.