Active Philips Respironics Field Service Actions
Our commitment to patient safety and quality is our top priority. Our promise to our patients and customers is that we will take action to ensure Philips Respironics solutions deliver safe and effective therapy.
Voluntary recall of CPAP and Bi-Level PAP Devices and Mechanical Ventilators (sound abatement foam)
Initiated June 2021
The foam that is used in some devices to reduce sound and vibration showed signs of degradation (damage) and chemical emissions. After careful analysis, Philips Respironics issued a Voluntary Recall Notification in the US and a Field Safety Notice in other markets.
Related issue: Trilogy 100/200
Initiated December 2022
Philips Respironics has detected an issue impacting Trilogy 100 and Trilogy 200 devices that were previously corrected by Philips Respironics as part of the ongoing correction of PE-PUR sound abatement foam. Post market surveillance data received by Philips Respironics indicate that these devices, which were remediated and now contain new foam, could experience a malfunction. This issue does not affect CPAP or BiPAP sleep apnea devices.
The replacement silicone sound abatement foam installed into the previously corrected Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm. Additionally, Philips Respironics has observed residual PE-PUR sound abatement foam in some devices that were returned to the field. These cases were limited but further exposure to PE-PUR sound abatement foam should be avoided.
Voluntary Field Safety Notice related to Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal
Initiated March 2023
Philips Respironics has discovered, through internal testing, that accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may vary based on the patient’s lung capacity, lung resistance, use of a particulate filter, or circuit configuration. In the worst case, this may lead to under delivery of oxygen.
The potential for this hazard is most likely to occur when the oxygen blending module (OBM) is used to manage patients requiring high volumes of oxygen such as scenarios requiring FiO2 setpoint greater than or equal to 70%.
Please note, these devices can continue to be safely used in line with the mitigations described within the Field Safety Notice.
Voluntary Field Safety Notice related to Trilogy Evo, Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal
Initiated April 2023
Philips Respironics has detected environmental contamination (e.g. dust and dirt) in the air path of some devices that have been returned from the field. Extended exposure to these environmental contaminants can lead to buildup of particulate on a flow sensor within the device. This may cause the device to inaccurately deliver pressure, volume, or flow. Using a particulate filter on the air inlet prevents the environmental contamination that can cause a device malfunction.
Please note, these devices can continue to be safely used in line with the mitigations described within the Field Safety Notice.
Voluntary field safety notice of V60 ventilator product family
Initiated October 2022
There is a possibility that affected ventilator units may cease to operate, potentially without setting off an audible/visual alarm (a so-called silent shutdown), and the patient may no longer receive respiratory assistance. Philips Respironics projects an average of less than one silent shutdown among one million uses per year.
Voluntary notification of labeling changes for masks with magnets
Initiated September 2022
This is a voluntary notification to inform users of specific sleep therapy masks containing magnetic components of updated instructions and labeling. Use of the mask is only contraindicated for patients and their household members, caregivers and bed partners that may be in close vicinity to patients using the masks, that have implanted metallic medical devices/metallic objects that may be affected by magnets.
These masks may continue to be used according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body.
Voluntary recall of certain BiPAP machines
Initiated August 2022
Philips’ subsidiary Philips Respironics has expanded its voluntary April 2021 recall notification/field safety notice for 43 A-series BiPAP ventilators (A30, A40, V30) containing a non-conforming plastic material in the blower motor to a total of approximately 1,700 A-series BiPAP and Omnilab Advance Plus ventilator units worldwide (including 386 units in the US).
If the non-confirming plastic is present in the device’s blower motor assembly, it could lead to off-gassing that would not occur in a blower motor that complies with company standards. The presence of the non-confirming plastic could also lead to sudden failure of the device during use. At the time of the expanded voluntary notification, Philips Respironics has not received any complaints related to this matter, nor of any patient harm. Philips Respironics has implemented actions to prevent future occurrences.
This expansion is not associated with the June 2021 recall notification/field safety notice in connection with the sound abatement foam in specific CPAP, BiPAP and mechanical ventilator devices. However, the expansion of the non-conforming plastic material recall notification does apply to some of the A-Series BiPAP and OmniLab Advance Plus devices in the June 2021 recall notification/field safety notice. All affected devices with the non-conforming plastic will therefore be remediated in the June 2021 field action.
