June 14, 2021
- Philips is initiating a voluntary recall notification* to make sure affected person security in session with regulatory companies
- Corrective actions embrace the deployment of up to date directions to be used and a restore and alternative program for affected units
- Philips goals to handle all affected units inside the scope of this correction as expeditiously as doable
Amsterdam, the Netherlands – Following the corporate update on April 26, 2021, Royal Philips (NYSE: PHG; AEX: PHIA) at the moment gives an replace on the recall notification* for particular Philips Bi-Degree Optimistic Airway Stress (Bi-Degree PAP), Steady Optimistic Airway Stress (CPAP), and mechanical ventilator units to handle recognized potential well being dangers associated to the polyester-based polyurethane (PE-PUR) sound abatement foam part in these units. The vast majority of the affected units inside the suggested 5-year service life are within the first-generation DreamStation product household.
To this point, Philips has produced hundreds of thousands of Bi-Degree PAP, CPAP and mechanical ventilator units utilizing the PE-PUR sound abatement foam. Regardless of a low grievance price (0.03% in 2020), Philips decided based mostly on testing that there are doable dangers to customers associated to this kind of foam. The dangers embrace that the PE-PUR foam could degrade into particles which can enter the system’s air pathway and be ingested or inhaled by the consumer, and the froth could off-gas sure chemical substances. The froth degradation could also be exacerbated by use of unapproved cleansing strategies, comparable to ozone,** and excessive warmth and excessive humidity environments might also contribute to foam degradation.
Due to this fact, Philips has determined to voluntarily challenge a recall notification* to tell sufferers and prospects of potential impacts on affected person well being and medical use associated to this challenge, in addition to directions on actions to be taken.
“We deeply remorse any concern and inconvenience that sufferers utilizing the affected units will expertise due to the proactive measures we’re saying at the moment to make sure affected person security,” stated Frans van Houten, CEO of Royal Philips. “In session with the related regulatory companies and in shut collaboration with our prospects and companions, we’re working exhausting in the direction of a decision, which incorporates the deployment of the up to date directions to be used and a complete restore and alternative program for the affected units. Affected person security is on the coronary heart of the whole lot we do at Philips.”
Recall notification* advise for sufferers and prospects
Based mostly on the most recent evaluation of potential well being dangers and out of an abundance of warning, the recall notification* advises sufferers and prospects to take the next actions:
- For sufferers utilizing affected BiLevel PAP and CPAP units: Discontinue use of your system and work together with your doctor or Sturdy Medical Gear (DME) supplier to find out essentially the most acceptable choices for continued therapy. To proceed use of your system attributable to lack of options, seek the advice of together with your doctor to find out if the good thing about persevering with remedy together with your system outweighs the dangers recognized within the recall notification.*
- For sufferers utilizing affected life-sustaining mechanical ventilator units: Don’t cease or alter your prescribed remedy till you’ve gotten talked to your doctor. Philips acknowledges that alternate ventilator choices for remedy could not exist or could also be severely restricted for sufferers who require a ventilator for life-sustaining remedy, or in circumstances the place remedy disruption is unacceptable. In these conditions, and on the discretion of the treating medical crew, the good thing about continued utilization of those ventilator units could outweigh the dangers recognized within the recall notification.*
Doable well being dangers
The corporate continues to observe studies of potential issues of safety as required by medical system laws and legal guidelines within the markets through which it operates. To this point, there have been no studies of loss of life because of these points. Philips has acquired studies of doable affected person impression attributable to foam degradation. The potential dangers of particulate publicity embrace headache, irritation, irritation, respiratory points, and doable poisonous and carcinogenic results. The potential dangers of chemical publicity attributable to off-gassing embrace headache, irritation, hypersensitivity, nausea/vomiting, and doable poisonous and carcinogenic results. Philips has acquired no studies relating to affected person impression associated to chemical emissions.
Restore and alternative program
Philips is offering the related regulatory companies with required info associated to the launch and implementation of the projected correction. The corporate will exchange the present sound abatement foam with a brand new materials and has already begun the preparations, which embrace acquiring the related regulatory clearances. Philips goals to handle all affected units in scope of this correction as expeditiously as doable.
As a part of this system, the first-generation DreamStation product households will probably be modified with a distinct sound abatement foam and shipped upon receipt of the required regulatory clearances. Philips’ lately launched next-generation CPAP platform, DreamStation 2, just isn’t affected by the problem. To assist this system, Philips is rising the manufacturing of its DreamStation 2 CPAP units, which can be out there within the US and chosen international locations in Europe.
When it comes to the monetary impression, Philips anticipates that the anticipated income headwinds within the Sleep & Respiratory Care enterprise in 2021 will probably be compensated by the energy of the corporate’s different companies. Due to this fact, the complete yr comparable gross sales progress and Adjusted EBITA margin steerage offered on April 26, 2021 stays unchanged.
The up to date directions to be used of the affected units have resulted in changes to and acceleration of the restore and alternative program, in addition to intensified communication with prospects and sufferers. This had led to a rise of EUR 250 million within the anticipated prices of the corrective actions on the put in base, along with the availability that the corporate recorded within the first quarter of 2021.
For extra info on the recall notification,* in addition to directions for patrons, customers and physicians, affected events could contact their native Philips consultant or go to www.philips.com/SRC-update.
* It is a recall notification for the US solely, and a area security discover for the remainder of the world
** Potential Dangers Related With The Use of Ozone and Ultraviolet (UV) Gentle Merchandise for Cleansing CPAP Machines and Equipment: FDA Safety Communication.
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Philips World Press Workplace
Tel.: +31 6 10888824
Philips Investor Relations
Tel.: +31 20 59 77222
About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a number one well being expertise firm centered on bettering folks’s well being and enabling higher outcomes throughout the well being continuum from wholesome residing and prevention, to prognosis, therapy and residential care. Philips leverages superior expertise and deep medical and shopper insights to ship built-in options. Headquartered within the Netherlands, the corporate is a frontrunner in diagnostic imaging, image-guided remedy, affected person monitoring and well being informatics, in addition to in shopper well being and residential care. Philips generated 2020 gross sales of EUR 17.3 billion and employs roughly 77,000 workers with gross sales and providers in additional than 100 international locations. Information about Philips may be discovered at www.philips.com/newscenter.
This launch incorporates sure forward-looking statements with respect to the monetary situation, outcomes of operations and enterprise of Philips and sure of the plans and goals of Philips with respect to those objects. Examples of forward-looking statements embrace statements made concerning the technique, estimates of gross sales progress, future EBITA, future developments in Philips’ natural enterprise and the completion of acquisitions and divestments. By their nature, these statements contain threat and uncertainty as a result of they relate to future occasions and circumstances and there are numerous elements that might trigger precise outcomes and developments to vary materially from these expressed or implied by these statements.