FDAFDA · Food and drugs·Recall number Z-0887-2021
Philips Respironics V60 Ventilator Part Number 1053615 - 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: October 30, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Respironics California, LLC
- Distributor
- Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AS, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE,NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of 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 Ventilator, Part Number 1053615 V60 Ventilator, Intl Opt: NONE Serial Numbers: 100011125 100021457 100049066 100049185 100049195 100049196 100049200 100122592 100172279 201003463 100011045 100013970 100013971 100015382 100097294 100106739 100109494 100109498 100109499 100109504 100110679 100120770 100036303 100036437 100036446 100036447 100036452 100120864 100085138 100101080 100160827 100006791 100006794 100006805 100007128 100007199 100007208 100007342 100010908 100011086 100011088 100011089 100011090 100011124 100011127 100011187 100013251 100013252 100013253 100013254 100013255 100013256 100013282 100013934 100014019 100014024 100014518 100015338 100015342 100015343 100015389 100015760 100016617 100016618 100016619 100016921 100016927 100016928 100016929 100017340 100017341 100017344 100017350 100017352 100017353 100019976 100020060 100020124 100020748 100020751 100020753 100020755 100020759 100020762 100020763 100021296 100021388 100021390 100021393 100021394 100029331 100029334 100029339 100029452 100029454 100029456 100029458 100029463 100036449 100049075 100049080 100049188 100049190 100049191 100049193 100049194 100052404 100052408 100052409 100067424 100067426 100067427 100067429 100067433 100067436 100067438 100067444 100067446 100068359 100068371 100068373 100068375 100068379 100071520 100071862 100071863 100071866 100071869 100071870 100071876 100071877 100071880 100071920 100073207 100073257 100073264 100074188 100074189 100074190 100074191 100074192 100074193 100074194 100086831 100086892 100087094 100087105 100087162 100087340 100087342 100087347 100087348 100087349 100091936 100091937 100092188 100092191 100092494 100092495 100092500 100092501 100092508 100092509 100100130 100100169 100100287 100100293 100100294 100100307 100100309 100100312 100100313 100100314 100114057 100114442 100114458 100114472 100114531 100114535 100114536 100114537 100114538 100114540 100114543 100114548 100114549 100115200 100115208 100115210 100115211 100115215 100115216 100115419 100118351 100118354 100118540 100118548 100118549 100118555 100118677 100118679 100118683 100118689 100125472 100125474 100125479 100125480 100125482 100125483 100147579 100172259 100172263 100172273 100176020 100176849 100182455 100182464 100184608 100185372 201000881 201000914 201001116 201001140 201001143 201001144 201001149 201002035 201002039 201002613 201002618 201002690 201002693 201002694 201002717 201002718 201002722 201003054 201003058 201003059 201003060 201003068 201003070 201003363 201003364 201003398 201003417 201003437 201003460 201003466 201003468 201003469 201003481 201004370 201009855 201009856 201009857 201009858 201009962 201009981 201009982 201009983 201009986 201009987 201010002 201010003 201010005 201010006 100006795 100007207 100007221 100007282 100007287 100007346 100010966 100010974 100011047 100011049 100011050 100011123 100011191 100014015 100014473 100014515 100014523 100014526 100014895 100015787 100015788 100016614 100016930 100017342 100017347 100017351 100017354 100017358 100021456 100024708 100024884 100024886 100024891 100053604 100053684 100053686 100054414 100055578 100055941 100055948 100055951 100055953 100055954 100056013 100056014 100064508 100071131 100073205 100078691 100078694 100084844 100089453 100089529 100089531 100089533 100089535 100092492 100094393 100101079 100101756 100101848 100101953 100102041 100102051 100106442 100107025 100114542 100114544 100114546 100114550 100118346 100120765 100125467 100125475 100125477 100125927 100125933 100126167 100126168 100126172 100136616 100136630 100136636 100143742 100143745 100148955 100148957 100169087
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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