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 potential
Amsterdam, the Netherlands – Following the corporate update on April 26, 2021, Royal Philips (NYSE: PHG; AEX: PHIA) at present gives an replace on the recall notification* for particular Philips Bi-Stage Constructive Airway Strain (Bi-Stage PAP), Steady Constructive Airway Strain (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.
Thus far, Philips has produced hundreds of thousands of Bi-Stage PAP, CPAP and mechanical ventilator units utilizing the PE-PUR sound abatement foam. Regardless of a low grievance fee (0.03% in 2020), Philips decided based mostly on testing that there are potential dangers to customers associated to any such foam. The dangers embrace that the PE-PUR foam might degrade into particles which can enter the gadget’s air pathway and be ingested or inhaled by the person, and the froth might off-gas sure chemical substances. The froth degradation could also be exacerbated by use of unapproved cleansing strategies, corresponding to ozone,** and excessive warmth and excessive humidity environments can also contribute to foam degradation.
Due to this fact, Philips has determined to voluntarily problem a recall notification* to tell sufferers and clients of potential impacts on affected person well being and scientific use associated to this problem, 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 present 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 clients and companions, we’re working onerous 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 every thing we do at Philips.”
Recall notification* advise for sufferers and clients
Based mostly on the newest evaluation of potential well being dangers and out of an abundance of warning, the recall notification* advises sufferers and clients to take the next actions:
- For sufferers utilizing affected BiLevel PAP and CPAP units: Discontinue use of your gadget and work along with your doctor or Sturdy Medical Gear (DME) supplier to find out probably the most acceptable choices for continued remedy. To proceed use of your gadget as a result of lack of alternate options, seek the advice of along with your doctor to find out if the good thing about persevering with remedy along with your gadget 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 will have talked to your doctor. Philips acknowledges that alternate ventilator choices for remedy might not exist or could also be severely restricted for sufferers who require a ventilator for life-sustaining remedy, or in instances the place remedy disruption is unacceptable. In these conditions, and on the discretion of the treating scientific workforce, the good thing about continued utilization of those ventilator units might outweigh the dangers recognized within the recall notification.*
Potential well being dangers
The corporate continues to observe studies of potential questions of safety as required by medical gadget rules and legal guidelines within the markets wherein it operates. Thus far, there have been no studies of demise on account of these points. Philips has obtained studies of potential affected person affect as a result of foam degradation. The potential dangers of particulate publicity embrace headache, irritation, irritation, respiratory points, and potential poisonous and carcinogenic results. The potential dangers of chemical publicity as a result of off-gassing embrace headache, irritation, hypersensitivity, nausea/vomiting, and potential poisonous and carcinogenic results. Philips has obtained no studies concerning affected person affect associated to chemical emissions.
Restore and alternative program
Philips is offering the related regulatory companies with required data associated to the launch and implementation of the projected correction. The corporate will substitute 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 potential.
As a part of this system, the first-generation DreamStation product households will likely be modified with a unique sound abatement foam and shipped upon receipt of the required regulatory clearances. Philips’ lately launched next-generation CPAP platform, DreamStation 2, will not be affected by the problem. To help 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 affect, Philips anticipates that the anticipated income headwinds within the Sleep & Respiratory Care enterprise in 2021 will likely be compensated by the energy of the corporate’s different companies. Due to this fact, the total yr comparable gross sales development 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 clients 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 data on the recall notification,* in addition to directions for purchasers, customers and physicians, affected events might contact their native Philips consultant or go to www.philips.com/SRC-update.
* It is a recall notification for the US solely, and a discipline 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.
For media and investor questions, please contact:
Philips International 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 targeted on enhancing individuals’s well being and enabling higher outcomes throughout the well being continuum from wholesome dwelling and prevention, to prognosis, remedy and residential care. Philips leverages superior expertise and deep scientific 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 could be discovered at www.philips.com/newscenter.
This launch comprises sure forward-looking statements with respect to the monetary situation, outcomes of operations and enterprise of Philips and sure of the plans and targets of Philips with respect to those objects. Examples of forward-looking statements embrace statements made in regards to the technique, estimates of gross sales development, future EBITA, future developments in Philips’ natural enterprise and the completion of acquisitions and divestments. By their nature, these statements contain danger and uncertainty as a result of they relate to future occasions and circumstances and there are various components that would trigger precise outcomes and developments to vary materially from these expressed or implied by these statements.