August 3, 2021 – A medical device recall has been issued by Philips Respironics in the U.S. for two of its ventilator products, the V60 and V60 Plus models. The FDA’s website has listed this as a Class I recall, which reads:
“The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.”
This is the second large medical device recall for Philips Electronics in less than a month, the first being its CPAP machine, this recall is not associated with that product, read about the CPAP machine recall here.
These V60 and V60 Plus ventilators offer high flow oxygen in a high concentration to provide patients with breathing assistance. These ventilators have a safety feature that limits the amount of flow delivered to the patients in situations where the system pressure reaches a default maximum pressure limit, due to a partial obstruction in the breathing circuit.
Here is the product information from the Philips website: The Respironics V60 ventilator is a microprocessor-controlled, bilevel positive airway pressure (BiPAP) ventilatory assist system that provides noninvasive positive pressure ventilation (NPPV) and invasive ventilatory support for spontaneously breathing adult and pediatric patients.
We have visited the FDA medical device recall page for the answer, here is the actual excerpt.
“Philips Respironics is recalling the V60 and V60 Plus ventilators that provide High Flow Therapy (Software Version 3.00 and Software Version 3.10) due to the risk to the patients who rely on the ventilator to provide high flow oxygen therapy if the system pressure reaches the default maximum limit. This can occur if the oxygen flow is partially blocked for any reason. If the issue causing maximum system pressure is not resolved by the health care provider, the ventilator will continue to provide the patient with lower oxygen flow rate and issue a low priority alarm. This could lead to serious adverse events, including death.”
There have been 61 incidents, 25 injuries, and no deaths reported for this issue.
After reviewing the FDA’s recall site, we checked with the Philips website to see their authorization notice for the U.S. it states for the V60 Plus product:
The V60 Plus and software version 3.00 or greater, is a modification to the existing FDA-cleared V60 ventilator and is therefore provided for use in accordance with FDA’s guidance, “Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency”, Section IV Policy for Modifications to FDA-Cleared Devices, issued March 2020. The V60 Plus ventilator is not FDA cleared or approved.
For more information about the Philips Respironics V60 or V60 Plus Ventilator Class I Recall and what you should do, please contact us directly at 1-800-631-5656. Our team of injury advocates at Schmidt National Law Firm is highly concerned about the risks associated with these recalled ventilators and is offering free consultations to anyone who uses these devices.
Our law firm is actively investigating these devices and potential injury cases resulting from the usage of these devices in an effort to help protect the health of ventilator users and hold manufacturers accountable.
Contact us today for a confidential consultation using the 100% secure form, or you can call us directly at 1-800-631-5656.
Philips Respironics Recalls V60 and V60 Plus Ventilators – FDA Class I Recall Page updated on August 3, 2021.