Reported Jul 28, 2021 · Ongoing
Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator…
Respironics California, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.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 with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals
- who require mechanical ventilationpatients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician
- Lot codes and dates
299 of 299 products · 299 lot codes
Recalled lot codes, grouped by product number US System Serial Number UDI Code 100371876(01)00884838090996(21)100371876
100373102(01)00884838090996(21)100373102
100374459(01)00884838090996(21)100374459
100376350(01)00884838090996(21)100376350
100377311(01)00884838090996(21)100377311
100377324(01)00884838090996(21)100377324
100380441(01)00884838090996(21)100380441
100382407(01)00884838090996(21)100382407
100382452(01)00884838090996(21)100382452
100382461(01)00884838090996(21)100382461
- Amount recalled
- Total of V60/V60 Plus = 23,115 systems
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Stop using this product now
It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 and 3.10), that includes a designed safety mechanism that limits the amount of pressure that can be delivered to a patient, in situations where the system pressure reaches the maximum limit and sounds the "Cannot Reach Target Flow" alarm , the system will reduce pressure and simultaneously decreasing the flow rate to a level below what was set by the clinicians. If the reason for the increase in pressure is not resolved, the ventilator will continue to provide the lower flow rate, which result in patients experiencing oxygen desaturation which can be characterized as moderate or severe hypoxemia.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Respironics California, LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.