Reported Feb 3, 2021 · Ongoing
Philips Respironics V60 Ventilator Part Number 1053613 - 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 1053613 - Product Usageintended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories
- Lot codes and dates
- ModelV60 Part Number 1053613 V60 Ventilator
- Intl OptCFLEX,AVAPS
- PP Serial numbers
2,137 of 2,137 codes
100029460100086827100106522100125955100173096100173294100173478100173526100173591100173593100173595100174299100174305100174308100190730100252781100252782100252785100304095100304097100304263100304264100304446100304447100304448100304451100304462201022963100190253201024196201025984201025987201025988100176847100176856100252776100315180100315377100315598100315602100315607100315610100315889100350701100361426100363749100370895100375246100044066100074200100074206100074207100085241100085243100085327100102145100102150100102152100102155100114031
- Amended 07/29/2021US Products
- that Faceplates will be replaced ModelV60 Part Number 1053613 V60 Ventilator
- Intl OptCFLEX,AVAPS
- PP US Serial Numbers
100051959100051964100051967100051968100094219100094345100095647100095648100095649100097381100181618100228824
- Amount recalled
- 2,137 systems (Amended on 07/29/2021 - 12 U.S. systems for faceplate replacement)
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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