Philips Respironics has recalled its V60 and V60 Plus Ventilators that are equipped with High Flow Therapy software versions 3.00 and 3.10 because of reduced oxygen risk.
On August 3, 2021, the U.S. Food and Drug Administration announced that the agency classified the recall of several Philips’ ventilators as Class 1, which is the FDA’s most severe recall classification. A Class I recall identified products that have been shown to cause “serious injuries or death.” This is a separate and new recall affecting Philips V60 series ventilators and is not associated with the June 2021 Philips Respironics ventilator, BiPAP, and CPAP machine recall.
This is Philip’s second Class I recall this year. In June, Philips recalled some of its breathing devices and ventilators due to the foam dampening material to make the machine quieter. However, the sound deadening material degrades over time and emits small particles that irritate airways and might be linked to cancer. The FDA reported the recalled products had been connected to 61 incidents with 25 injuries.
Philips stated that it is recalling its V60 and V60 Plus ventilators due to a risk of users breathing in reduced oxygen under certain circumstances, leading to adverse events to users. According to Philips, the affected breathing machines devices have a design safety mechanism that limits the amount of oxygen flow when the system pressure approaches a “default maximum pressure limit due to a partial obstruction in the breathing circuit.” This can cause the user to suffocate and potentially due to Asphyxia. Asphyxia is a potentially deadly medical condition a condition that occurs when the body suffers oxygen deprivation. Oxygen deprivation leads to unconsciousness and then death by suffocation.
Philip has FDA has identified this as a Class I recall, the most serious type of recall. The FDA also warns that the use of the recalled breathing machines could cause serious injuries or death.
The Philips Ventilators
The FDA announced a second Class I recall to impact Philips’ sleep and respiratory care division in just a few weeks. The recalled ventilators can involuntarily lower the oxygen flow rate leading to injuries, brain injuries, organ damage, or death by oxygen deprivation.
Philips initiated the recall was initiated June 18, 2021, and has recalled more than 16,500 units. The recalled breathing machines have distribution dates: May 1, 2009, to June 2, 2021
Philips’ ventilators are designed to administer high-flow oxygen therapy to are affected by the recall. The ventilators are used in hospitals for patients who need emergency, mechanical breathing support, such as those suffering chronic respiratory insufficiency, obstructive sleep apnea, or respiratory failure.
The Reason for Recall
Last June, Philips informed patients and healthcare providers that the V60 and V60 Plus devices’ that the company identified cases of partial blockage with specific lines of their ventilators and the breathing circuits causes the devices to provide a lower oxygen flow than is required, potentially resulting in serious adverse events or even death. The primary issue involves the ventilator’s safety mechanism, which limits the oxygen flow passed to the user. If the system reaches the default maximum pressure limits, it emits a low-priority alarm. A blockage to the flow of oxygen can raise the pressure and trigger the safety cutoff, which can prevent the breathing machine from reaching the required level of oxygen flow. This issue can cause severe adverse events, including death.
The FDA’s recall notice states that a total of 61 incidents and 25 injuries have been connected to the issue, and no deaths have been reported at this time.
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