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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Respironics V60 Ventilator

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 Class 2 Device Recall Philips Respironics V60 Ventilatorsee related information
Date Initiated by FirmNovember 02, 2020
Date PostedJanuary 22, 2021
Recall Status1 Open3, Classified
Recall NumberZ-0916-2021
Recall Event ID 86697
510(K)NumberK082660 
Product Classification Ventilator, continuous, minimal ventilatory support, facility use - Product Code MNT
ProductPhilips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. Philips Respironics V60 Ventilator Part Number U1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. Note: U1053617 added 1/29/2021 after noticing it had been inadvertently left off
Code Information Model: V60 Part Number: DU1053617 V60 Ventilator, US Demo Units Serial Numbers: 100002908 100002911 100002913 100002914 100002916 100002959 100003001 100003003 100003005 100003007 100003018 100003046 100003052 100003081 100003674 100003675 100003685 100003689 100003728 100003736 100003757 100003909 100003910 100003913 100003916 100003918 100003919 100004032 100004033 100004077 100004081 100004120 100004122 100004123 100004124 100004125 100004127 100004128 100004131 100004320 100004322 100004323 100004324 100004325 100004508 100004542 100004543 100004545 100004547 100004549 100004550 100004553 100004554 100004555 100004556 100004557 100004558 100004620 100004621 100004622 100004623 100004624 100004625 100004626 100004627 100004982 100004983 100004984 100004985 100004986 100004987 100004988 100004992 100004994 100004995 100004999 100005110 100005116 100005117 100005141 100005147 100005150 100005239 100005241 100005242 100005247 100005251 100005334 100005338 100005347 100005388 100005486 100005489 100005491 100005595 100005690 100005697 100005699 100005987 100006282 100006368 100006884 100006887 100006892 100006893 100006932 100006934 100007044 100007345 100007635 100007712 100008137 100008145 100008148 100008354 100008359 100008422 100008425 100008432 100008644 100008650 100008657 100008854 100008943 100008999 100009000 100009087 100009097 100009098 100009334 100009776 100009856 100009858 100009960 100009973 100010102 100010167 100010202 100010205 100010232 100010518 100011305 100011778 100012044 100012282 100012284 100012290 100012291 100012358 100012542 100012545 100012770 100012896 100012968 100013483 100013600 100013629 100013665 100013666 100013673 100013674 100013675 100015786 100016534 100017356 100024283 100024300 100025783 100025793 100025947 100026813 100026818 100026825 100026948 100027405 100027421 100027744 100029670 100029674 100029677 100029679 100029680 100029682 100029687 100029696 100029698 100029831 100029834 100029836 100029837 100029840 100029841 100029843 100029845 100029846 100029847 100029848 100029851 100029852 100029853 100029854 100029856 100029857 100029860 100030028 100030030 100030033 100030034 100031683 100032466 100032471 100032473 100032474 100032477 100032478 100032479 100032539 100033462 100034676 100034677 100034680 100034691 100034696 100034806 100034807 100034810 100034821 100035425 100035617 100035734 100035745 100035748 100035750 100035751 100035752 100035753 100035757 100035758 100037766 100037774 100037775 100038022 100038420 100038429 100038595 100038597 100038599 100038600 100038608 100038611 100038710 100038712 100038713 100038718 100038719 100038722 100038723 100038725 100038726 100038730 100038733 100039252 100040159 100040163 100040166 100040758 100040848 100040850 100040852 100040854 100040855 100040856 100041393 100041394 100042014 100042015 100042016 100042018 100042019 100042020 100042023 100042024 100042025 100042026 100042027 100042030 100042115 100043383 100043388 100043389 100043390 100043391 100043392 100043393 100043394 100043395 100043420 100043421 100043422 100043427 100043428 100043429 100043433 100043435 100043437 100043709 100043711 100044618 100044621 100044628 100044630 100044632 100044633 100044634 100044635 100044637 100044639 100044640 100044641 100044643 100044772 100044773 100044775 100044779 100044792 100044793 100044794 100044795 100044796 100044923 100045121 100045292 100045835 100045836 100045837 100045838 100045839 100045840 100045841 100045843 100045844 100045846 100045847 100045848 100045849 100045850 100045851 100045852 100045853 100045854 100045856 100045857 100045858 100045859 100045860 100045861 100045862 100046015 100046016 100046017 100046018 100046019 100046020 100046021 100046022 100046023 100046024 100046026 100046029 100046030 100046031 100046032 100046034 100047834 100047835 100048013 100048866 201000040 201000041 201000042 201000043 201000044 201000045 201000046 201000047 201000048 201000049 201000050 201000051 201000052 201000053 201000054 201000055 201000065 201000067 201000078 201000079 201000096 201000097 201000098 201000099 201000100 201000128 201000129 201000130 201000131 201000132 201000133 201000134 201000135 201000145 201000146 201000147 201000148 201000150 201000152 201000153 201000154 201000155 201000156 201000175 201000176 201000196 201000198 201000200 201000201 201000202 201000220 201000297 201000298 201000311 201000312 201000313 201000314 201000315 201000316 201000330 201000331 201000333 201000334 201000337 201000338 201000339 201000340 201000341 201000343 201000380 201000381 201000383 201000384 201000385 201000491 201000494 201000496 201001638 201002012 201002131 201002137 201002138 201002139 201002460 201002461 201002462 201002480 201002556 201002557 201002565 201002571 201002590 201002591 201002597 201002629 201002647 201002651 201002663 201002785 201002802 201002967 201003277 201003279 100031561 Model: V60 Ventilator, Part Number U1053617 V60 Ventilator, USED ENGL OPT:CFLEX, AVAPS,PPV,AT+ Note: U1053617 added 1/29/2021 after noticing it had been inadvertently left off Serial Numbers: 100260233 100269324 100259732 100259863 100012867 100013831 100019589 100025024 100025938 100026001 100026663 100027660 100027968 100030595 100037381 100042754 100049903 100057035 100062238 100063161 100065043 100065047 100072563 100073252 100073254 100074566 100075395 100075396 100075409 100076087 100078252 100078850 100079007 100081754 100082656 100084977 100088335 100090937 100092047 100092057 100092309 100092442 100092544 100092969 100093791 100094690 100094731 100097992 100098699 100099976 100100750 100100856 100101065 100101404 100101408 100105454 100106192 100106406 100106521 100106590 100106715 100106884 100109744 100110298 100110378 100110458 100110478 100110479 100110485 100110489 100110598 100110610 100110673 100112876 100114470 100114525 100116572 100118818 100119210 100120753 100120821 100121402 100121456 100121686 100121815 100125763 100125926 100129587 100129595 100130458 100133611 100136136 100136643 100136655 100141903 100146850 100146852 100147180 100147797 100149576 100149714 100153310 100158909 100160567 100160569 100165175 100166344 100172321 100173098 100173451 100173878 100174081 100174140 100176545 100179474 100179478 100180773 100182557 100187312 100188343 100189912 100191275 100192793 100193226 100194905 100195660 100195872 100195875 100195889 100195891 100195892 100195899 100195968 100195969 100195970 100195978 100196000 100196002 100196004 100196005 100196006 100196007 100196008 100196010 100196012 100196013 100196015 100196016 100196017 100196018 100196019 100196020 100196021 100196022 100196100 100196101 100196103 100196104 100196106 100196107 100196108 100196109 100196110 100196111 100196112 100196113 100196114 100196115 100196117 100196118 100196119 100196120 100196121 100196122 100196123 100196124 100196125 100196126 100196128 100196129 100196130 100196131 100196132 100196134 100196135 100196136 100196137 100196139 100196400 100196401 100196403 100196406 100196407 100196408 100196409 100196410 100196411 100196413 100196414 100196415 100196416 100196417 100196418 100196419 100196420 100196421 100196422 100196423 100196424 100196425 100196426 100196427 100196428 100196434 100196619 100219464 100219967 100221176 100223855 100224350 100224708 100224970 100226526 100230373 100232632 100236034 100236968 100238071 100238136 100239821 100241846 100244859 100246583 100248301 100249178 100251889 100252101 100252951 100254743 100254960 100256421 100256849 100263569 100269325 100278293 100279592 100280589 201000762 201000769 201000770 201001941 201002494 201004093 201004394 201005787 201007765 201008139 201009340 201009889 201009948 201010587 201011021 201013041 201013786 201014044 201015018 201015057 201015083 201015127 201015481 201017700 201021042 201021044 201023087 201023345 201024350 201024382 201024385 201024483 201024747 201026183 201027175 201027359 201028921 201029423 201029806 201029966 201029975 201030285 201030856 201031934 201031987 Amended 07/29/2021: US Products that Faceplates will be replaced Part Number: DU1053617 V60 Ventilator, US Demo Units Serial Numbers: 100002908 100002911 100002913 100002914 100002916 100002959 100003001 100003003 100003005 100003007 100003018 100003046 100003052 100003081 100003674 100003675 100003685 100003689 100003728 100003736 100003757 100003909 100003910 100003913 100003916 100003918 100003919 100004032 100004033 100004077 100004081 100004120 100004122 100004123 100004124 100004125 100004127 100004128 100004131 100004320 100004322 100004323 100004324 100004325 100004508 100004542 100004543 100004545 100004547 100004549 100004550 100004553 100004554 100004555 100004556 100004557 100004558 100004620 100004621 100004622 100004623 100004624 100004625 100004626 100004627 100004982 100004983 100004984 100004985 100004986 100004987 100004988 100004992 100004994 100004995 100004999 100005110 100005116 100005117 100005141 100005147 100005150 100005239 100005241 100005242 100005247 100005251 100005334 100005338 100005347 100005388 100005486 100005489 100005491 100005595 100005690 100005697 100005699 100005987 100006282 100006368 100006884 100006887 100006892 100006893 100006932 100006934 100007044 100007345 100007635 100007712 100008137 100008145 100008148 100008354 100008359 100008422 100008425 100008432 100008644 100008650 100008657 100008854 100008943 100008999 100009000 100009087 100009097 100009098 100009334 100009776 100009856 100009960 100009973 100010102 100010167 100010202 100010205 100010232 100010518 100011305 100011778 100012044 100012282 100012284 100012290 100012291 100012358 100012542 100012545 100012770 100012896 100012968 100013483 100013600 100013629 100013665 100013666 100013673 100013674 100013675 100015786 100016534 100017356 100024283 100024300 100025783 100025793 100025947 100026813 100026818 100026825 100026948 100027405 100027421 100027744 100029670 100029674 100029677 100029679 100029680 100029682 100029687 100029696 100029698 100029831 100029834 100029836 100029837 100029840 100029841 100029843 100029845 100029846 100029847 100029848 100029851 100029852 100029853 100029854 100029856 100029857 100029860 100030028 100030030 100030033 100030034 100031561 100031683 100032466 100032471 100032473 100032474 100032477 100032478 100032479 100032539 100033462 100034676 100034677 100034680 100034691 100034696 100034806 100034807 100034810 100034821 100035425 100035617 100035734 100035745 100035748 100035750 100035751 100035752 100035753 100035757 100035758 100037766 100037774 100037775 100038022 100038420 100038429 100038595 100038597 100038599 100038600 100038608 100038611 100038710 100038712 100038713 100038718 100038719 100038722 100038723 100038725 100038726 100038730 100038733 100039252 100040159 100040163 100040166 100040758 100040848 100040850 100040852 100040854 100040855 100040856 100041393 100041394 100042014 100042015 100042016 100042018 100042019 100042020 100042023 100042024 100042025 100042026 100042027 100042030 100042115 100043383 100043388 100043389 100043390 100043391 100043392 100043393 100043394 100043395 100043420 100043421 100043422 100043427 100043428 100043429 100043433 100043435 100043437 100043709 100043711 100044618 100044621 100044628 100044630 100044632 100044633 100044634 100044635 100044637 100044639 100044640 100044641 100044643 100044772 100044773 100044775 100044779 100044792 100044793 100044794 100044795 100044796 100044923 100045121 100045292 100045835 100045836 100045837 100045838 100045839 100045840 100045841 100045843 100045844 100045846 100045847 100045848 100045849 100045850 100045851 100045852 100045853 100045854 100045856 100045857 100045858 100045859 100045860 100045861 100045862 100046015 100046016 100046017 100046018 100046019 100046020 100046021 100046022 100046023 100046024 100046026 100046029 100046030 100046031 100046032 100046034 100047834 100047835 100048013 100048866 201000040 201000041 201000042 201000043 201000044 201000045 201000046 201000047 201000048 201000049 201000050 201000051 201000052 201000053 201000054 201000055 201000065 201000067 201000078 201000079 201000096 201000097 201000098 201000099 201000100 201000128 201000129 201000130 201000131 201000132 201000133 201000134 201000135 201000145 201000146 201000147 201000148 201000150 201000152 201000153 201000154 201000155 201000156 201000175 201000176 201000196 201000198 201000200 201000201 201000202 201000220 201000297 201000298 201000311 201000312 201000313 201000314 201000315 201000316 201000330 201000331 201000333 201000334 201000337 201000338 201000339 201000341 201000343 201000380 201000381 201000383 201000384 201000385 201000491 201000494 201000496 201001638 201002012 201002131 201002137 201002138 201002139 201002460 201002461 201002462 201002480 201002556 201002557 201002565 201002571 201002590 201002591 201002597 201002629 201002647 201002651 201002663 201002785 201002802 201002967 201003277 201003279 Amended 07/29/2021: US Products that Faceplates will be replaced Part Number: U1053617 V60 USED ENGL OPT:CFLEX, AVAPS,PPV,AT+ Serial Numbers: 100012867 100013831 100019589 100025024 100025938 100026001 100026663 100027660 100027968 100030595 100037381 100042754 100049903 100057035 100062238 100063161 100065043 100065047 100072563 100073252 100073254 100074566 100075395 100075396 100075409 100076087 100078252 100078850 100079007 100081754 100082656 100084977 100088335 100090937 100092047 100092057 100092309 100092442 100092544 100092969 100093791 100094690 100094731 100097992 100098699 100099976 100100750 100100856 100101065 100101404 100101408 100105454 100106192 100106406 100106521 100106590 100106715 100106884 100109744 100110298 100110378 100110458 100110478 100110479 100110485 100110489 100110598 100110610 100110673 100112876 100114470 100114525 100116572 100118818 100119210 100120753 100120821 100121402 100121456 100121686 100121815 100125763 100125926 100129587 100129595 100130458 100133611 100136136 100136643 100136655 100141903 100146850 100146852 100147180 100147797 100149576 100149714 100153310 100158909 100160567 100160569 100165175 100166344 100172321 100173098 100173451 100173878 100174081 100174140 100176545 100179474 100179478 100180773 100182557 100187312 100188343 100189912 100191275 100192793 100193226 100194905 100195660 100195872 100195875 100195889 100195891 100195892 100195899 100195968 100195969 100195970 100195978 100196000 100196002 100196004 100196005 100196006 100196007 100196008 100196010 100196012 100196013 100196015 100196016 100196017 100196018 100196019 100196020 100196021 100196022 100196100 100196101 100196103 100196104 100196106 100196107 100196108 100196109 100196110 100196111 100196112 100196113 100196114 100196115 100196117 100196118 100196119 100196120 100196121 100196122 100196123 100196124 100196125 100196126 100196128 100196129 100196130 100196131 100196132 100196134 100196135 100196136 100196137 100196139 100196400 100196401 100196403 100196406 100196407 100196408 100196409 100196410 100196411 100196413 100196414 100196415 100196416 100196417 100196418 100196419 100196420 100196421 100196422 100196423 100196424 100196425 100196426 100196427 100196428 100196434 100196619 100219464 100219967 100221176 100223855 100224350 100224708 100224970 100226526 100230373 100232632 100236034 100236968 100238071 100238136 100239821 100241846 100244859 100246583 100248301 100249178 100251889 100252101 100252951 100254743 100254960 100256421 100256849 100263569 100269325 100278293 100279592 100280589 201000762 201000769 201000770 201001941 201002494 201004093 201004394 201005787 201007765 201008139 201009340 201009889 201009948 201010587 201011021 201013041 201013786 201014044 201015018 201015057 201015083 201015127 201015481 201017700 201021042 201021044 201023087 201023345 201024350 201024382 201024385 201024483 201024747 201026183 201027175 201027359 201028921 201029423 201029806 201029966 201029975 201030285 201030856 201031934 201031987
Recalling Firm/
Manufacturer		 Respironics California, LLC
2271 Cosmos Ct
Carlsbad CA 92011-1517
For Additional Information Contact
800-722-9377
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Device Design
ActionOn 11/02/2020, the firm sent an "URGENT-MEDICAL DEVICE CORRECTION" Notification Letter via priority mail informing customer that the V60 Ventilators may experience two potential issues with the navigation ring interface (see table below for additional information). 1. The navigation ring may become inoperative or begin operating intermittently. 2. The navigation ring may not behave as expected, making it difficult for the user to change ventilator settings via the touchscreen. and if clinicians accept an incorrect setting and leaves the patient on the ventilator without responding to the resulting alarms, the patient could sustain serious injuries. Customers are instructed: 1. When cleaning V60 ventilators, do not allow cleaning agents to pool on the ventilator surfaces. This is especially important on the device interface. 2. Check setting changes before and after accepting the changes. 3. If the navigation ring becomes inoperative or operates intermittently during clinical use, use the touchscreen for all settings changes and navigation, and contact Philips to schedule service following clinical use. 4. If the navigation ring interferes with your ability to adjust therapy settings via touchscreen, remove the ventilator from service and contact Philips for repair. and to please review the following sections of the user manual: 1. Chapter 10: Care and maintenance. To prevent possible damage to the ventilator when cleaning, use only those cleaning and disinfecting agents listed, and do not drip or spray any liquids directly onto any ventilator surface. 2. Chapter 1: Warnings, cautions, and notes. During clinical use of the ventilator, monitor patients for changes in respiratory status with each ventilator setting adjustment. Use an external oxygen monitor to verify oxygen concentration, and have an alternative means of ventilation available whenever a ventilator is in use. Customers are also instructed to complete, sign and return the Acknowledgement and Receipt
Quantity in Commerce481 systems (DU1053617)(Amended 07/29/2021 - 44,666 U.S. systems for faceplate replacement), and 292 systems (U1053617) (Amended 07/29/2021 - 7,770)
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MNT
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