Reported Feb 3, 2021 · Ongoing

Philips Respironics V60 Ventilator Part Number 1053614 - 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 1053614 - 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 Number1053614 V60 Ventilator
  • Intl OptCFLEX
  • AVAPS Serial numbers

    3,252 of 3,252 codes

    • 100007217
    • 100021204
    • 100021286
    • 100021400
    • 100029451
    • 100042750
    • 100042939
    • 100043085
    • 100055703
    • 100056018
    • 100062163
    • 100062178
    • 100063153
    • 100063155
    • 100063162
    • 100063293
    • 100063300
    • 100069697
    • 100069744
    • 100069860
    • 100070577
    • 100070772
    • 100132058
    • 100133634
    • 100144871
    • 100144874
    • 100144879
    • 100144961
    • 100144982
    • 100162731
    • 100162792
    • 100169641
    • 100195675
    • 100219970
    • 100219972
    • 100219975
    • 100219999
    • 100220001
    • 100221150
    • 100239619
    • 100243227
    • 100246517
    • 100247269
    • 100252596
    • 100252597
    • 100252600
    • 100252764
    • 100252768
    • 100252771
    • 100252772
    • 100252773
    • 100252797
    • 100253477
    • 100253484
    • 100253492
    • 100253493
    • 100253494
    • 100253500
    • 100254739
    • 100286208
Amount recalled
9,856 systems (Amended on 07/29/2021 - 5 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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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:46 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.