With this letter, we would like to address the questions you may have about the EOVE products, following the Philips voluntary recall notification for the US* and for several products part of its CPAP, Bi-Level PAP and ventilation ranges. The Philips FSN* is due to “two issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in Philips Continuous and NonContinuous Ventilators”.
* see Philips’ June 14, 2021 press release announcing the voluntary recall notification for the US and rest-of-world field safety notice.
Frequently asked questions
1 – Are the devices produced by EOVE affected by the Philips’ recall?
The EOVE medical devices are NOT subject to the Philips recall notification.
2 – Can the EOVE devices be used safely?
The EO-150 has been on the market since 2015 and represents an installed base of thousands of devices to date. No case of deterioration of the foams has been reported so far and further investigations allow us to state that the EOVE devices can be used safely, in accordance with their intended use.
We confirm that EOVE does NOT use the same material of sound abatement foam as the one used by Philips. The EOVE medical devices are not subject to the Philips recall notification.
3 – Does EOVE use foam in its devices?
We confirm that EOVE uses sound abatement foams, which is an usual practice for this kind of devices. However, EOVE does NOT use the same material of sound abatement foam as the one used by Philips. The EO-70, the secretion management device, does NOT include any sound abatement foam. The EOVE medical devices are not subject to the Philips recall notification.
4 – Do EOVE devices use other foams than the sound abatement foams?
EO-150 and EO-70 have two other foams: one is used to filter the flow and the other one is used to filter the air inlet. Both are changed frequently, at least during maintenance operations that require the device to be opened. The analysis of our claim reports allows us to confirm that neither an incident nor a symptom relating to a potential deterioration of the foams present in the EO-150, has been reported or observed on the field.
5 – What are EOVE’s recommendations for cleaning and disinfecting its devices?
Considering the EO-150 cleaning and disinfection process, especially for the patient airpath, EOVE authorizes Ozone or hydrogen peroxide solution (Keredusy system) where necessary and in accordance with the instructions listed in the applicable Maintenance Manual (see chapter 14.3). It is important to note that this kind of process is authorized only five (5) times over the total lifetime of the device and must be followed after each cycle by the replacement of the turbine and its sound abatement foam, thus eliminating the risk of degradation due to this disinfection process.
Do not hesitate to contact us for any further question you may have.