Philips recalled Trilogy Evo, Trilogy EV300, Trilogy Evo O2 and Trilogy Evo Universal ventilators to fix new and previously reported problems with the devices.

The company issued a mandatory update in July 2024 to fix problems including false alarms, inaccurate oxygen displays, data corruption and other software errors. 

Philips also added a requirement for a particulate filter to prevent buildup of dust or debris in the machines. The company updated the instructions for use to add missing contraindications and fix translation mistakes.

Use of the devices could result in a lack of ventilation or oxygen, the FDA said in an Oct. 1, 2024, notice. The agency said there have been reports of nine injuries and one death.

Philips said in a statement that the recall affects about 90,000 units worldwide, including about 67,000 in the U.S. A Philips spokesperson wrote in an email that the notice “indicates how prior field safety notices are being corrected,” and addresses “new non-safety issues.” 

It also includes information on labeling and instruction manual updates, the Philips spokesperson wrote. 

Read the FDA notice.

The DOJ filed a consent decree of permanent injunction that would bar Philips from selling sleep apnea devices and ventilators in the U.S. until it meets terms set out by the FDA. The final agreement sets out a roadmap for Philips and the actions it must take to come into compliance.

Those actions include paying for an independent expert to to test the silicone-based foam the company used in new and reworked machines. Additionally, the company must hire an outside auditor to inspect certain Respironics facilities in the U.S. for five years. 

Philips is also required to implement a recall remediation plan that includes providing patients with new or reworked devices, or a partial refund. The company can export devices not being used to support patients whose machines were recalled, but it can't sell them in the U.S. until certain FDA requirements are met. 

Read the filing.

Philips recalled its Omnilab Advanced Plus ventilator because a false “ventilator inoperative” alarm can cause the machine to shut down. The device is used to perform titration studies, which determine the correct settings for sleep apnea treatment.

The recall includes more than 9,000 devices distributed in the U.S. and more than 2,600 distributed in Canada, according to a May 23, 2024 FDA database entry. 

Philips said it has not received any reports of patient harm related to the recalled devices. The company said it is investigating the problem and customers may continue to use their system according to the instructions for use and the field safety notice.

Read the filing. 

Philips recalled three models of bilevel positive airway pressure (BiPAP) ventilators because a false alarm can cause the machines to shut down. The problem can potentially result in patients not receiving enough ventilation, mild to severe hypoxemia, hypercarbia, respiratory failure or death, according to an FDA recall notice posted on May 24, 2024. 

The recall applies to Philips’ BiPAP A30, BiPAP A40, and BiPAP V30 ventilators, accounting for more than 87,000 devices, according to FDA database entries. 

Philips said in a statement it has received reports of 10 serious injuries and seven deaths associated with the A30 and A40 devices between 2011 and 2023, adding that “investigation of these reports could not conclusively determine causation.” 

The devices can continue to be used per their instructions and a field safety notice the company issued in March 2024, Philips said. 

Read the filing.

Philips recalled several models of ventilators for a software malfunction that can cause devices to suddenly lose ventilation. A battery depleted or loss of power alarm can alert even when the units have sufficient power, according to an FDA database entry posted on April 17, 2024.

The recall includes Philips’ Trilogy Evo, Garbin Evo, Aeris Evo and Lifevent Evo2 ventilators, affecting more than 146,500 units. Philips also alerted authorities in the Netherlands to the problem in early April. The company has not reported any related injuries. 

A Philips spokesperson said the company plans to address the problem through a software update that is available in the U.S. and will be available in relevant countries outside the U.S. within the quarter. 

If an alarm goes off, users should immediately plug the machine into a power source, or remove and replace the detachable battery. Until the software update is implemented, Philips said the affected devices can continue to be used according to their instructions and the guidance provided in the field safety notice. 

Read the FDA notice

Philips recalled some of its V60 ventilators after finding that power management printed circuit board assemblies may malfunction. This could cause power failure and for the ventilator to stop working. The V60 devices are used to provide mechanical ventilation for hospital patients. 

The recall affects a total of nine devices, including eight in the U.S., according to an FDA database entry posted Sept. 28, 2023. 

The ventilators are not always used in the ICU, and there may be greater risk to patients in other hospital settings where they are not directly monitored, according to an FDA notice. 

Philips instructed customers to discontinue use of the affected ventilators until they are contacted by a representative to remove or replace the circuit board assemblies. 

Read the FDA notice

Philips recalled four models of its Trilogy Evo portable ventilators after finding that the buildup of dust or dirt could block the air vents, leading the devices to stop delivering the right amount of air pressure or air flow. The ventilators are used to provide CPAP or breathing support for people who need mechanical ventilation. 

The recall includes 73,000 devices in the U.S., according to an FDA notice updated in August 2023. 

Philips said its particulate filter, which was once optional, is now required. The company received 542 reports related to the problem, including two injuries and one death, according to the FDA. 

Read the FDA notice

Philips recalled some of its Trilogy Evo portable ventilators after finding that the accuracy of delivered oxygen can deviate from the setpoint when providing high-concentration oxygen therapy. An internal sensor, if equipped, could also give higher oxygen concentration readings than the device is actually delivering. 

The problem affects a total of 62,826 devices, the FDA said in an April 2023 database entry. 

Clinicians can continue to use the affected devices, but should monitor patients’ oxygen saturation levels and use an external monitor when delivering high-concentration oxygen. The company also recommended that they have a backup device available. 

Read the FDA notice

Sleep apnea machines that had been repaired for foam problems were recalled again after Philips found that they had been programmed with incorrect or duplicate serial numbers. The problem could result in patients being treated with the wrong prescription settings, or they may not receive any therapy at all.  

The recall includes 1,088 DreamStation devices in the U.S., according to an FDA notice posted in April 2023. 

The company said patients should continue to use their device until they receive a replacement or until a healthcare provider can make pressure changes. 

Philips received 43 complaints about this issue, according to the FDA.

Read the FDA notice

After reworking some of its Trilogy and Garbin Plus ventilators as part of the foam recall, Philips recalled them again after finding new problems with the replacement foam installed in the devices. Silicone foam used to replace the PE-PUR soundproofing foam can separate from the plastic backing, and could block the airpath. In a portion of the devices, PE-PUR sound abatement foam was found in ventilators that were returned to customers. 

The recall includes 13,811 ventilators distributed in the U.S., according to an FDA notice updated in February 2023. 

For ventilator-dependent patients, Philips recommended transitioning to an alternative ventilator, and quarantining all impacted devices that are removed from service.

Read the FDA notice

Philips recalled masks used with its CPAP and BiPAP machines because the magnets used to hold them in place could pose a risk to people who have implanted metallic devices. For example, the masks could harm people with pacemakers, aneurysm clips, metallic cranial plates and neurostimulators. Philips recommended that people using one of these devices stop using the mask and switch to a non-magnetic one, if available. 

The recall includes more than 18.6 million masks in the U.S., according to an FDA notice updated in January. There were 43 complaints, including 14 reports of serious injuries as of Sept. 9, 2022. 

Read the FDA notice

Philips found that some of its BiPAP machines may contain plastic contaminated with a non-compatible material. The contaminated plastic may release volatile organic compounds if the plastic is in the device’s motor, which can cause headaches, dizziness or irritation.

The recall included 386 devices in the U.S., according to an FDA notice updated in December 2022. 

Read the FDA notice

Philips flagged an electrical fault in its V60 and V60 Plus ventilators that can cause the devices to stop working. An internal power fluctuation can cause the ventilators to shut down, sometimes without warning. The resulting shutdown could result in patients being deprived of oxygen for an extended period of time, according to an FDA notice updated in June 2022.

The problem affects 56,671 devices in the U.S., the FDA said. The agency had received reports of four injuries and one death as of April 2022. 

Read the FDA notice

Philips recalled a portion of its V60 and V60 Plus ventilators because a subset of the devices included parts put together using expired adhesive. If the adhesive fails, a support bracket could come loose and potentially damage the capacitors, causing the ventilator to stop working. 

The recall included 1,511 devices in the U.S., according to an FDA notice updated in March 2022. 

Read the FDA notice

After recalling millions of CPAP machines, BiPAP machines and ventilators in June for the use of PE-PUR foam, Philips found more devices that used the same soundproofing foam. The company began a recall of a subset of its Trilogy Evo ventilators and repair kits after finding a supplier incorrectly used PE-PUR foam in the muffler assembly for the devices. 

The problem applied to 215 ventilators and 51 repair kits in the U.S., according to a January 2022 FDA notice. Philips said it would replace the affected devices. 

Read the FDA notice

Philips issued a recall of some of its V60 and V60 Plus ventilators that are equipped with high flow therapy, because they may provide the patient with a lower oxygen flow rate. If oxygen flow for the device is blocked for any reason, the system may reach a default maximum pressure limit. 

The problem affected 16,535 devices in the U.S., and Philips reported 61 incidents and 25 injuries, according to an August 2021 FDA notice.

Read the FDA notice

Philips recalled several BiPAP machines and ventilators for the use of PE-PUR foam to soundproof the devices. The foam could break down into small particles that could be swallowed or inhaled while patients use the devices, causing difficulty breathing, swelling, or toxic reactions, according to the FDA. 

The recall included 204,776 devices in the U.S., and Philips had received 83 complaints at the time, according to an FDA notice posted in July 2021.

Read the FDA notice

Philips began its recall of millions of CPAP and BiPAP machines in June 2021 due to the use of PE-PUR sound abatement foam, which can break down and be swallowed or inhaled by patients. 

Exposure to the debris or chemicals could cause serious adverse events including irritation, inflammation, asthma, and toxic carcinogenic effects, according to an FDA notice updated in July 2021.

The recall includes more than 15.3 million devices, including more than 10.3 million in the U.S. and 5 million in other countries, according to entries in the FDA’s recall database.  Between April 2021 and March 2023, the FDA received more than 105,000 reports related to the foam problems, including 385 reports of death.

Philips is still in the process of repairing and replacing the affected devices.

Read the FDA notice

In 2018, Philips issued a corrective action for some of its ventilators after finding that PE-PUR foam may degrade into particles. The company added foam replacement to the preventive maintenance schedule for those devices.

At the time, Philips did not disclose the change to the FDA. The agency discovered the problem during a facility inspection in 2021. Inspection documents reviewed by MedTech Dive showed the company had received dozens of complaints about the foam degrading dating back to 2014. 

The FDA posted the correction in its database in March of 2022, after Philips had begun a broader recall of the devices related to the foam problem. 

Read the FDA notice