Reported Jul 28, 2021 · Ongoing

Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an…

Respironics California, LLC

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Respironics California, LLC · 2271 Cosmos Ct · Carlsbad, CA · 92011-1517

Is this the product you have?

  • Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals
  • who require mechanical ventilationpatients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician
Lot codes and dates
  • Model V60 Ventilator
    • P/N 1053613
    • 1053614
    • 1053615
    • 1053616
    • 1053617
    • DU1053617
    • U1053617
    • 1076716
    • 1137292
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    (01)00884838020054(21)100219461 100030612 100194307 (01)00884838020054(21)100194307
    • 100141908
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    • 100103903
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    • 201015055
    • 100008064
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    (01)00884838020054(21)100321030 100151261 100094893 201002554 100376321 (01)00884838020054(21)100376321 100129531 100100458 100021832 100271329 (01)00884838020054(21)100271329 100032480 100313205 (01)00884838020054(21)100313205 100317516 (01)00884838020054(21)100317516 100016741 201014801 100308413 (01)00884838020054(21)100308413
    • 100084648
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    • 201009840
    • 201019632
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    (01)00884838020054(21)100246095 100226211 (01)00884838020054(21)100226211
    • 100069460
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    (01)00884838020054(21)100287018 100080132 100172596 100356227 (01)00884838020054(21)100356227 100109731 201021047 100263576 (01)00884838020054(21)100263576
    • 100088719
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    • 201018025
    • 100168616
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    • MX0001282
    (01)00884838020054(21)MX0001282 100184947 100073400 100026608 100131419 100283908 (01)00884838020054(21)100283908 100086414 100150050 100120436 100193230 100023426 100231683 (01)00884838020054(21)100231683 100006702 100263123 (01)00884838020054(21)100263123 100162173 100012868 100147666 100366526 (01)00884838020054(21)100366526 100032466 100152913 100405716 (01)00884838020054(21)100405716
    • 100085041
    • 100133402
    • 100012013
    • 100097820
    • 100048191
    • 100141127
    • 100146937
    • 100325532
    (01)00884838020054(21)100325532 100122265 100109638 100266148 (01)00884838020054(21)100266148 100303075 (01)00884838020054(21)100303075 100275316 (01)00884838020054(21)100275316
    • 100113480
    • 100094902
    • 100149266
    • 201015963
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    • 100039407
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    (01)00884838020054(21)100272251 100254975 (01)00884838020054(21)100254975 100295496 (01)00884838020054(21)100295496 100255292 (01)00884838020054(21)100255292 201026729 (01)00884838020054(21)201026729 100358924 (01)00884838020054(21)100358924 201000812 100090444 100364111 (01)00884838020054(21)100364111 100188448 100071618 100295209 (01)00884838020054(21)100295209 201029414 (01)00884838020054(21)201029414 100179763 100059719 100130366 100063470 201026989 (01)00884838020054(21)201026989 100031668 100141800 100237788 (01)00884838020054(21)100237788
    • 100085816
    • 100082652
    • 201017931
    • 100112564
    • 201017003
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    • 100177838
    • 100126519
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    • 100341090
    (01)00884838020054(21)100341090 201001581 100182554 100043824 100238926 (01)00884838020054(21)100238926 100030481 100126512 201035555 (01)00884838020054(21)201035555 100025991 100258929 (01)00884838020054(21)100258929 100072203 100042033 100063898 100081325 100021509 100193625 100308031 (01)00884838020054(21)100308031 100092035 100026943 201025122 (01)00884838020054(21)201025122 100065168 100271321 (01)00884838020054(21)100271321 100337334 (01)00884838020054(21)100337334 100265704 (01)00884838020054(21)100265704 100112656 100295495 (01)00884838020054(21)100295495 100240321 (01)00884838020054(21)100240321
    • 100038802
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    • 100193008
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    • 100064423
    • 100177871
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    (01)00884838020054(21)201027365 100028944 100273497 (01)00884838020054(21)100273497
    • 100028950
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    • 100082333
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    (01)00884838020054(21)100222615
    • 100087268
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    • 201015058
    • 100029690
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    (01)00884838020054(21)100227577 100299596 (01)00884838020054(21)100299596 100229562 (01)00884838020054(21)100229562 100140437 100230444 (01)00884838020054(21)100230444
    • 100048636
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    • 100093248
    • 100191900
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    • 100072843
    • 100026620
    • 100073353
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    • 100039408
    • 201016621
    • 100148657
    • 100259394
    (01)00884838020054(21)100259394 100109268 100223781 (01)00884838020054(21)100223781 100372400 (01)00884838020054(21)100372400 100032536 100068393 201003183 100295215 (01)00884838020054(21)100295215 100082095 100249308 (01)00884838020054(21)100249308
    • 100072281
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    (01)00884838020054(21)100230486 100124740 100281722 (01)00884838020054(21)100281722
    • 100051223
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    (01)00884838020054(21)100288829
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    (01)00884838020054(21)100327223 201032016 (01)00884838020054(21)201032016 100194710 (01)00884838020054(21)100194710 100302369 (01)00884838020054(21)100302369 100030460 100095334 100141507 100034039 100063602 100008649 100275527 (01)00884838020054(21)100275527
    • 100057523
    • 100066318
    • 100037651
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    (01)00884838020054(21)100379369 100085367 100295633 (01)00884838020054(21)100295633 100299585 (01)00884838020054(21)100299585 100272103 (01)00884838020054(21)100272103 100250575 (01)00884838020054(21)100250575 100062642 100300900 (01)00884838020054(21)100300900 100299448 (01)00884838020054(21)100299448 100289849 (01)00884838020054(21)100289849 100031667 100066905 100187244 100030834 201038152 (01)00884838020054(21)201038152 100263673 (01)00884838020054(21)100263673 100299300 (01)00884838020054(21)100299300
    • 100006365
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    • 100081558
    • 100047388
    • 100050003
    • 100016012
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    (01)00884838020054(21)100371791 100112577 201034617 (01)00884838020054(21)201034617 201034622 (01)00884838020054(21)201034622 201019550 100148007 100065700 100031000 100240662 (01)00884838020054(21)100240662 MX0001821 (01)00884838020054(21)MX0001821 100303069 (01)00884838020054(21)100303069 100103239 100113098 201029515 (01)00884838020054(21)201029515 100093442 100068595 201030025 (01)00884838020054(21)201030025 100092059 100273693 (01)00884838020054(21)100273693 100158649 100193806 100427792 100121330 100006895 100266679 (01)00884838020054(21)100266679 100107656 100368889 (01)00884838020054(21)100368889 OUS (International)
  • System Serial Number/UDI Code100410528 (01)00884838089297(21)100410528 100342563 100261002 (01)00884838009851(21)100261002 100391108 (01)00884838089297(21)100391108 100345521 100027294 201033669 (01)00884838009851(21)201033669 100078694 100029332 100378456 (01)00884838009851(21)100378456 100143739 100144969 100243519 (01)00884838009851(21)100243519 100341392 (01)00884838009851(21)100341392 201029945 (01)00884838009851(21)201029945 100221160 (01)00884838009851(21)100221160 100368048 (01)00884838009851(21)100368048
    • 100071881
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    • 100175815
    • 100139917
    • 100189486
    • 100071130
    • 100172257
    • 201013817
    • 201002709
    • 100078696
    • 100003246
    • 100086773
    • 100118670
    • 100088051
    • 100189489
    • 201002273
    • 100247417
    (01)00884838009851(21)100247417 100346921 (01)00884838009851(21)100346921 100176338 100278791 (01)00884838009851(21)100278791 100285001 (01)00884838009851(21)100285001 100190085 100006111 100230029 (01)00884838009851(21)100230029 100244201 (01)00884838009844(21)100244201 100179385 100239534 (01)00884838009851(21)100239534 201029776 (01)00884838009851(21)201029776 100110677 100243224 (01)00884838009851(21)100243224 100348087 (01)00884838009851(21)100348087 100144874 100179382 100229633 (01)00884838009844(21)100229633 100378459 (01)00884838089297(21)100378459 100410514 100315894 100126161 100133620 100094393 100144981 100230026 (01)00884838009851(21)100230026 100233964 (01)00884838009851(21)100233964 100015334 201022999 (01)00884838009851(21)201022999 100244590 (01)00884838009851(21)100244590 100028670 201029115 (01)00884838009851(21)201029115 100006114 100118695 100176847 100110846 100371670 (01)00884838009851(21)100371670 100189477 100189480 100078367 100169650 100172258 100381925 (01)00884838009851(21)100381925 201010821 100166085 100043299 100045681 201029918 (01)00884838009851(21)201029918 100234781 (01)00884838009851(21)100234781 100219997 (01)00884838009851(21)100219997 100082433 100104065 100024697 100011191 100259879 (01)00884838009851(21)100259879 201033640 (01)00884838009851(21)201033640 100237375 (01)00884838009851(21)100237375 100247101 (01)00884838009851(21)100247101 100289690 100189819 100254748 (01)00884838009851(21)100254748 100116378 201033644 (01)00884838009851(21)201033644 100237374 (01)00884838009844(21)100237374 201002710 100104055
Amount recalled
Total of V60/V60 Plus = 23,115 systems

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

Stop using this product now

It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 and 3.10), that includes a designed safety mechanism that limits the amount of pressure that can be delivered to a patient, in situations where the system pressure reaches the maximum limit and sounds the "Cannot Reach Target Flow" alarm , the system will reduce pressure and simultaneously decreasing the flow rate to a level below what was set by the clinicians. If the reason for the increase in pressure is not resolved, the ventilator will continue to provide the lower flow rate, which result in patients experiencing oxygen desaturation which can be characterized as moderate or severe hypoxemia.

Using this product could cause serious injury, illness or death — stop using it now.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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By hazard

Other recalls from Respironics California, LLC

Where it was distributed

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:21 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.