Philips V60 Ventilator with Version 2.20 Software, Description: V 60 Ventilator,Intl Opt: CFLEX,AVAPS,PPV V60…
Medical device recall Z-1687-2017. Published in FDA’s Enforcement Report on Apr 5, 2017.
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 Apr 5, 2017. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 2512 units 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?
The V60 Ventilator with Version 2.20 software installed may falsely detect that the blower motor has stalled. If this condition occurs, the software will cause the ventilator to shut down (Vent Inop) and display Error Code 100E. Ventilatory support will cease.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Philips V60 Ventilator with Version 2.20 Software, Description: V 60 Ventilator,Intl Opt: CFLEX,AVAPS,PPV V60 Ventilator,Intl Opt: CFLEX,AVAPS V60 Ventilator,Intl Opt: None V60 Ventilator,English Opt: None V60 Ventilator,Engl Opt: CFLEX,AVAPS V60 Us Demo Unit V60 USED ENGL OPT:CFLEX, AVAPS,PPV,AT+cl V60 VENT, JAPAN OPT: CFLEX, AVAPS, AT+ V60 VENT, JAPAN OPT: CFLEX, AVAPS, AT+ Catalog/REF No. 1053613, 1053614, 1053615, 1053616, 1053617, DU1053617, U1053617, 1076709, R1076709
2512 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Number 100190253 100195884 201023008 201024196 201025984 201025987 201025988 201025947 201025972 201025996 201026002 201023858 201026449 201026531 201026645 201026658 201026668 201025266 201026252 201026254 201026431 201026433…
Every code shown here, 1,994 characters
Serial Number 100190253 100195884 201023008 201024196 201025984 201025987 201025988 201025947 201025972 201025996 201026002 201023858 201026449 201026531 201026645 201026658 201026668 201025266 201026252 201026254 201026431 201026433 201026434 201026435 201026436 201026439 201026569 201026577 201026579 201026598 201026601 201026605 201026636 201026639 201026640 201026642 201026646 201026649 201026651 201026652 201026653 201026655 201026659 201026662 201026665 201026667 201026672 201026673 201026680 201026685 201026686 201026687 201026689 201026690 201026691 201026692 201026693 201026694 201026695 201026699 201026700 201026701 201026702 201026705 201026706 201026708 201026709 201026710 201026711 201026712 201026715 201026716 201026717 201026741 201026742 201026744 201026748 201026749 201026753 201026755 201026765 201026782 201024190 201026534 201025309 201025864 201025994 201026438 201024086 201025167 201025173 201025179 201025382 201025402 201025871 201026660 201026671 201026681 201023832 201023850 201023856 201023871 201024010 201024061 201026525 201026568 201026570 201026573 201026574 201026575 201026576 201026602 201026641 201026647 100189742 100189753 100190088 100190090 100190095 100190735 100190738 100190809 100190810 100190811 100190813 100195313 100195319 100195649 100195864 100195896 201022731 201022737 201022738 201022761 201022768 201023092 201023097 201023100 201023101 201023845 201026524 201026567 201026592 201026688 201026704 201026719 201026746 201026752 201026256 201026257 201026532 201026572 201026578 201026644 201026650 201026661 201026714 201026740 201026757 201026780 100190093 100190737 100195641 201023886 201024070 201022727 201023091 201023674 201023675 201024188 201024189 201024193 201024194 201024195 201024198 201024199 201025160 201025166 201025169 201025170 201025171 201025172 201025174 201025175 201025176 201025180 201025185 201025190 201025193 201025194 201025197 201025296 201025316 201025394 201025396 201025397 201025399 201025401…
FDA’s list runs to 25,133 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 - US Distribution and to the countries of : Argentina, Austria, Belgium, Canada, Czech Republic, Finland, France, Germany, Hong Kong, Iceland, India, Indonesia, Italy, Japan, Kuwait, Malaysia, Mexico, Netherlands, Norway, Qatar, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom and Vietnam.
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 Feb 1, 2017.
- FDA classified it on Mar 27, 2017.
- FDA’s Enforcement Report published it on Apr 5, 2017.
- FDA terminated it on Jun 26, 2018.
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 25,133 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
-
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.