Reported Feb 3, 2021 · Ongoing
Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be used only with various…
Respironics California, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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
- Part Number DU1053617 - Product Usageintended 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 Usageintended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories
- NoteU1053617 added 1/29/2021 after noticing it had been inadvertently left off
- Lot codes and dates
- ModelV60
- Part NumberDU1053617 V60 Ventilator
- US Demo Units Serial Numbers
481 of 481 codes
100002908100002911100002913100002914100002916100002959100003001100003003100003005100003007100003018100003046100003052100003081100003674100003675100003685100003689100003728100003736100003757100003909100003910100003913100003916100003918100003919100004032100004033100004077100004081100004120100004122100004123100004124100004125100004127100004128100004131100004320100004322100004323100004324100004325100004508100004542100004543100004545100004547100004549100004550100004553100004554100004555100004556100004557100004558100004620100004621100004622
- Model
V60 VentilatorPart Number U1053617 V60 Ventilator
- USED ENGL OPTCFLEX, AVAPS,PPV,AT+
- NoteU1053617 added 1/29/2021 after noticing it had been
- inadvertently left off Serial Numbers
292 of 292 codes
100260233100269324100259732100259863100012867100013831100019589100025024100025938100026001100026663100027660100027968100030595100037381100042754100049903100057035100062238100063161100065043100065047100072563100073252100073254100074566100075395100075396100075409100076087100078252100078850100079007100081754100082656100084977100088335100090937100092047100092057100092309100092442100092544100092969100093791100094690100094731100097992100098699100099976100100750100100856100101065100101404100101408100105454100106192100106406100106521100106590
- Amended 07/29/2021US Products that
- Faceplates will be replaced Part NumberDU1053617 V60 Ventilator
- US Demo Units Serial Numbers
479 of 479 codes
100002908100002911100002913100002914100002916100002959100003001100003003100003005100003007100003018100003046100003052100003081100003674100003675100003685100003689100003728100003736100003757100003909100003910100003913100003916100003918100003919100004032100004033100004077100004081100004120100004122100004123100004124100004125100004127100004128100004131100004320100004322100004323100004324100004325100004508100004542100004543100004545100004547100004549100004550100004553100004554100004555100004556100004557100004558100004620100004621100004622
- Amended 07/29/2021US Products that
- Faceplates will be replaced Part NumberU1053617
- V60 USED ENGL OPTCFLEX, AVAPS,PPV,AT+
- Serial Numbers
288 of 288 codes
100012867100013831100019589100025024100025938100026001100026663100027660100027968100030595100037381100042754100049903100057035100062238100063161100065043100065047100072563100073252100073254100074566100075395100075396100075409100076087100078252100078850100079007100081754100082656100084977100088335100090937100092047100092057100092309100092442100092544100092969100093791100094690100094731100097992100098699100099976100100750100100856100101065100101404100101408100105454100106192100106406100106521100106590100106715100106884100109744100110298
- Amount recalled
- 481 systems (DU1053617)(Amended 07/29/2021 - 44,666 U.S. systems for faceplate replacement), and 292 systems (U1053617) (Amended 07/29/2021 - 7,770)
This recall covers 33 products
The agency filed one notice per product. You are reading one of them; the other 32 are below.
20 more are in the archive.
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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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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