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
100007217100021204100021286100021400100029451100042750100042939100043085100055703100056018100062163100062178100063153100063155100063162100063293100063300100069697100069744100069860100070577100070772100132058100133634100144871100144874100144879100144961100144982100162731100162792100169641100195675100219970100219972100219975100219999100220001100221150100239619100243227100246517100247269100252596100252597100252600100252764100252768100252771100252772100252773100252797100253477100253484100253492100253493100253494100253500100254739100286208
- 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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