FDAFDA · Food and drugs·Recall number Z-0903-2021
Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Published February 3, 2021 · Recall initiated: November 2, 2020
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Respironics California, LLC
- Distributor
- Worldwide distribution - US Nationwide including Guam and Puerto Rico; Afghanistan, Albania, Algeria, Andorra, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bhutan, Bolivia, Brazil, Bulgaria, Burkina Faso, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, Finland, France, French Guiana, French Polynesia, Germany, Ghana, Gibraltar, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Latvia, Lebanon, Libya, Luxembourg, Malaysia, Maldives, Mali, Malta, Mexico, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, ST. Pier Miquel, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Vietnam, Wallis Futuna, and Zambia.
- Lot
- Model: V60 Part Number: 1053614 V60 Ventilator,Intl Opt: CFLEX,AVAPS Serial numbers: 100007217 100021204 100021286 100021400 100029451 100042750 100042939 100043085 100055703 100056018 100062163 100062178 100063153 100063155 100063162 100063293 100063300 100069697 100069744 100069860 100070577 100070772 100132058 100133634 100144871 100144874 100144879 100144961 100144982 100162731 100162792 100169641 100195675 100219970 100219972 100219975 100219999 100220001 100221150 100239619 100243227 100246517 100247269 100252596 100252597 100252600 100252764 100252768 100252771 100252772 100252773 100252797 100253477 100253484 100253492 100253493 100253494 100253500 100254739 100286208 100286300 100311170 100317381 100317392 100318233 100318405 100318406 100318408 100318413 100318415 100318416 100318426 100318615 100318623 100336755 100336849 100336855 100336889 100336895 100336900 100337085 100337258 100337260 100337261 100343560 100344202 100344235 100350181 100350684 100350711 100350714 100350914 100351156 100351157 100352118 100352139 100352147 100357135 100357137 100357139 100357454 100357456 100357458 100357459 100357733 100357797 100358125 100358129 100358131 100358134 100358149 100358151 100358154 100358155 100358162 100358164 100358198 100358302 100358304 100358319 100358337 100362568 100362701 100363015 100363053 100364545 100364554 100364602 100365186 100370897 100373551 100375010 100375148 100375226 100375243 100375267 100375280 100375282 100375283 201002610 201002611 201002976 201023090 201025859 201025954 201025966 201028012 201028033 201028528 201028889 201028898 201028988 201028990 201029030 201029045 201029138 201029937 201032702 201032705 201032707 201032713 201032718 201032733 201032831 201032863 201032871 100350289 100350298 100350670 100351154 100351541 100351555 100351712 100352113 100352824 100352946 100358347 100361419 100362450 100362575 100362703 100362721 100362745 100362746 100363013 100363030 100364252 100364503 100364521 100364532 100364539 100364562 100364571 100364611 100364621 100364624 100365161 100365162 100365164 100365166 100365177 100365183 100368067 100368558 100368607 100368610 100368723 100368883 100369414 100369417 100369424 100369425 100369436 100373445 100375009 100375149 100375167 100375174 100375178 100375233 100375241 100375262 100375268 100375284 100375290 100375293 100375298 100375385 100375396 100376391 100377940 100378200 100378203 100378210 100378214 100378216 100378221 100378283 100378294 100378442 100378443 100378444 100378880 100378892 100378939 100380812 100027294 100061625 100061627 100061638 100061640 100061641 100084756 100120124 100120850 201003948 201009965 201009974 201032704 201032710 201032725 201032729 201032732 100003563 100004666 100004675 100004678 100004680 100004682 100004794 100004925 100006184 100007337 100007347 100010849 100010903 100010970 100011091 100011194 100011195 100011196 100011198 100020662 100022039 100022051 100022143 100022149 100022156 100022242 100029333 100036292 100036295 100042755 100042758 100042940 100044361 100044523 100046904 100050526 100052770 100055815 100055827 100055949 100061645 100061646 100061800 100063157 100063159 100068212 100069748 100069869 100069956 100075310 100082432 100082437 100082464 100092493 100095598 100095651 100101751 100101759 100101760 100110676 100110939 100122334 100122348 100132026 100132038 100132040 100132045 100132051 100133642 100148954 100162739 100162898 100176025 100184198 100189658 100195894 100219977 100230168 100233962 100252963 100253497 100254783 100260028 100260973 100261125 100261128 100261133 100261274 100261276 100266756 100266759 100266760 100266761 100266762 100266763 100266764 100266765 100266769 100266770 100267525 100267526 100267530 100267560 100277907 100277915 100284354 100285014 100286315 100378291 100378296 201000741 201000886 201001542 201003492 201004663 201009219 201009463 201009470 201022987 201022991 201025947 201025972 201025996 201026002 201029036 201029659 201029876 201029952 2010
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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