Reported Feb 3, 2021 · Ongoing
Philips Respironics V60 Ventilator Part Number 1053618 - 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 1053618 - 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 Number1053618 V60 Ventilator
- Japan OptCFLEX
- AVAPS Serial Numbers
534 of 534 codes
100019618100019631100019639100019822100019823100019824100019827100019838100019917100019920100019922100019924100019965100019966100019967100019971100019972100020663100020664100020665100020666100022148100023892100023893100023894100023896100023897100023899100023905100023909100023940100023941100023944100023956100023995100023998100024000100024003100024007100024008100024688100025546100025549100026087100026088100026089100026090100026092100026095100026124100027090100027095100027100100027101100027108100027114100027174100027176100027181100027185
- Amount recalled
- 534 systems
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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