Reported Feb 3, 2021 · Ongoing
Philips Respironics V60 Plus Ventilator Part Number 1138747 - 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 Plus Ventilator
- Part Number 1138747 - 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
- Plus Part Number1138747 V60 Plus Ventilator
- US Serial Numbers
682 of 682 codes
100360666100363973100365901100365983100365987100366525100366542100367657100367660100367732100370559100371789100371876100371995100372119100372901100372903100373102100373106100373116100373117100374141100374143100374149100374168100374169100374171100374236100374238100374283100374285100374287100374291100374406100374410100374453100374456100374458100374459100376350100376351100377022100377275100377278100377304100377307100377315100377334100378833100378838100379236100379341100379350100379351100379352100379368100379432100379438100379462100379465
- Amended 07/29/2021US Products
- that Faceplates will be replaced ModelV60
- Plus Part Number1138747 V60 Plus Ventilator
- US Serial Numbers
2,556 of 2,556 codes
100360666100363973100365901100365983100365987100366525100366542100367642100367657100367660100367732100370559100371789100371876100371995100372119100372347100372901100372903100373102100373106100373116100373117100374141100374143100374144100374149100374168100374169100374170100374171100374236100374238100374283100374285100374287100374291100374406100374410100374453100374456100374457100374458100374459100374460100376350100376351100377022100377275100377278100377281100377293100377304100377305100377307100377310100377311100377314100377315100377316
- Amount recalled
- 682 systems (Amended on 07/29/2021 - 15,185 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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