Reported Feb 3, 2021 · Ongoing
Philips Respironics V60 Ventilator Part Number 1053616 - 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 1053616 - 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 Number1053616 V60 Ventilator
- English OptNone
- Serial Numbers
330 of 330 codes
100087733100087738100087932100087999100088155100004031100004071100004073100005244100005350100005351100005599100006209100006210100006217100006406100006701100006702100006881100006883100006886100006888100006891100006929100006933100006939100006940100006941100009417100009501100009512100009513100009549100009550100009553100009554100009556100009566100009679100009760100009761100009762100009768100009769100009770100009777100009812100009816100009854100010206100010242100010390100010514100010515100010517100010519100011308100011343100011344100011468
- Amended 07/29/2021US Products
- that Faceplates will be replaced ModelV60
- Part Number1053616 V60 Ventilator
- English OptNone
- Serial Numbers
325 of 325 codes
100004031100004071100004073100005244100005350100005351100005599100006209100006210100006217100006406100006701100006702100006881100006883100006886100006888100006891100006929100006933100006939100006940100006941100009417100009501100009512100009513100009549100009550100009553100009554100009556100009566100009679100009760100009761100009762100009768100009769100009770100009777100009812100009816100009854100010206100010242100010390100010514100010515100010517100010519100011308100011343100011344100011468100011740100011741100011744100011749100011750
- Amount recalled
- 330 systems (Amended on 07/29/2021 - 44,841 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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