More than 1,600 Philips Respironics V60 and V60 Plus ventilators are being recalled, due to a risk they may fail to deliver enough oxygen to some patients, which has resulted in more than two dozen patient injuries to date.
The FDA announced the Philips V60 Ventilator recall on August 3, warning about a risk for patients relying on the High Flow Therapy system to provide them with high amounts of oxygen. According to the recall notice, the manufacturer has received reports of at least 61 incidents where the system failed to provide the appropriate oxygen flow, which resulted in at least 25 injuries. However, no deaths have been reported to date.
The V60 and V60 Plus ventilators are used to give breathing assistance to patients who require higher concentrations of oxygen at higher flow rates than usual oxygen therapy. They come equipped with a safety feature which prevents the ventilators from delivering too much oxygen if the system pressure reaches a default maximum pressure limit.
This safety feature appears to be part of the problem, however. According to the recall notice, if the oxygen flow is partially blocked for any reason, the system can reach its maximum default limit and not provide enough oxygen to the patient. If this happens it will issue a low priority alarm. However, if the problem is not resolved by a health care provider, the lower flow of oxygen to the patient can result in serious adverse health events and even death.
The recall impacts V60 Plus ventilators and all V60 ventilators upgraded to enable High Flow Therapy (software version 3.00 and 3.10). The recalled devices were distributed between May 1, 2009 and June 2, 2021. An estimated 16,535 devices sold in the U.S. are affected by the recall notice.
Philips Respironics, the manufacturer, sent an “Urgent Field Safety Notice” to customers in June, alerting them to the problem and recommending they continuously monitor patients’ oxygen saturation when on the affected devices. They also urged health care providers to respond to all of the alarms urgently, regardless of priority and not to use high flow therapy if the patient could not be constantly and closely monitored.
The FDA determined the notice constituted a Class I recall; the most serious recall classification, meaning the agency believes problems with the recalled ventilators could lead to serious patient injuries or deaths.
Philips CPAP, BiPAP and Ventilator Recall
This latest recall comes after Philips removed millions of CPAP, BiPAP and ventilators from the market in mid-June. The Philips CPAP recall came after the company determined the devices were distributed with unsafe and defective sound abatement foam that may degrade and release black particles or toxic chemicals directly into the lungs of users who rely on the devices for treatment of sleep apnea and other conditions.
Exposure to the toxic particles and gases released by a polyester-based polyurethane (PE-PUR) foam inside has been linked to reports of cancer, severe respiratory problems and other health complications, according to allegations raised in a growing number of Philips CPAP recall lawsuits filed over the past few weeks.
Due to concerns about the serious health risks, the FDA issued a safety communication on June 30, urging people who use Philips DreamStation, CPAP or BiPAP machines to immediately stop using their device and contact their healthcare providers for a suitable treatment alternative.