Philips Respironics Inc is recalling its V60 ventilators and V60 plus ventilators, in keeping with a discover on the US Meals and Drug Administration’s (FDA) web site. The ventilators comprise energy administration printed circuit board assemblies that had been distributed by a third-party warehouse and don’t meet ventilator requirements, per the discover.
The FDA has recognized this as a Class I recall, probably the most severe sort of recall. Use of those units might trigger severe accidents or dying. This recall is a voluntary correction, not a product elimination.
Philips Respironics V60 ventilators and V60 plus ventilators are used to supply respiratory help to pediatric and grownup sufferers. A ventilator is meant to mechanically management or help affected person respiratory by delivering a predetermined proportion of oxygen. V60 ventilators and V60 plus ventilators are supposed for use inside hospitals.
The V60 ventilators and V60 plus ventilators are usually not at all times utilized in intensive care models the place sufferers are straight monitored. There could also be larger danger for sufferers who are usually not straight monitored in different hospital settings.
Using the affected ventilators might trigger severe hostile well being penalties, together with energy failure, lack of ventilator operate, and dying. There have been no experiences of dying or accidents associated to this recall.
- Product names: Philips Respironics V60 ventilators and V60 plus ventilators
- Product codes: See recall database entry
- Distribution dates: Might 6 to Might 6
- Units recalled within the US: Eight
- Date initiated by agency: Aug 25
On Aug 25, Philips despatched all affected clients an Pressing Medical Machine Correction letter. The letter requested clients to discontinue use of the units and quarantine them. A Philips Respironics consultant will contact the purchasers. The consultant will present directions to take away or substitute the Energy Administration PCBAs within the affected units.