Reported Feb 3, 2021 · Ongoing
Philips Respironics V60 Ventilator Part Number 1053617 - 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 1053617 - 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 Number1053617 V60 Ventilator
- English OptNone
- Serial Numbers
3,252 of 3,252 codes
201000151100109977100090432100091177100091771100092004100092037100113859100008140100009121100066005100067771100068862100068864100068866100229881100229933100229936100244028100244036100244037100342231201013345201030470201030473201030478MX0000810MX0000813MX0000825MX0000828100002909100002910100002912100002915100002998100002999100003000100003002100003004100003006100003019100003040100003041100003042100003043100003044100003045100003047100003048100003049100003050100003051100003053100003080100003082100003083100003084100003085100003086100003087
- Amount recalled
- 46,247 systems (Amended on 07/29/2021 - 52,164 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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