Wen 丨 Hu Xiang Yun
For Philips, the past week has not been peaceful.
First of all, on June 14th, Forbes magazine said that Philips is recalling as many as 4 million respirators, mainly because a foam material used in these devices has the potential to degrade and release hazardous and potentially carcinogenic substances.
A few days later, on June 17, China's State Food and Drug Administration (SFDA) issued two notices announcing the recall of 28,494 non-invasive ventilators and x-ray computed tomography (CT) devices*** under the Philips banner. Among them, 28,450 ventilators were already sold in China. The main reason for the recall is that the foam used in the devices may be hazardous to human health.
The Health and Safety Commission found that in the first half of this year alone, the State Food and Drug Administration (SFDA) has issued 18 recall notices related to Philips, *** involving more than 100,000 units of various types of ventilators, imaging equipment, monitors, and other products.
"Polyester-type polyurethane (PE-PUR) sound-deadening foam", the dominoes of Philips is pushed down by it.
Publicly available information shows that the PE-PUR noise-reducing foam used in these breathing devices degrades into particles under certain conditions , posing a risk of being ingested or inhaled by the user and potentially leading to headaches, irritation, nausea, vomiting, and so on, and even being potentially carcinogenic. But so far, there have been no official reports of deaths caused by these devices.
Earlier, Philips official spokesman Steve Klink said in an interview with Reuters that "80% of the devices affected are CPAP ventilators used by sleep apnea patients" on the recall list. The device is primarily used to treat sleep apnea syndrome, which is apnea caused by snoring, among other things.
A CPAP ventilator is a continuous positive airway pressure ventilation ventilator, in addition to BiPAP, a ventilator with bi-level positive airway pressure ventilation.As of today, Philips*** counts millions of devices such as BiPAP, CPAP, and mechanical ventilators, which have PE-PUR sound-absorbing foam in them. The data shows that the rate of user complaints against these devices in 2020 was only about 0.03%, but Philips still decided to deal with it with a proactive recall.
In China, Philips has also begun a recall of related products. on June 17, the State Drug Administration announced that Weikang Medical Products (Shenzhen) Co. Ltd. has announced a recall of more than 20,000 non-invasive respiratory devices with the model number of the Dorma 500 Auto, again because of the PE-PUR sound-deadening foam. Wellcome Medical is one of Philips' ventilator manufacturing bases in the Asia-Pacific region.
In response to the recall, Philips has allocated a total of 500 million euros (about 3.9 billion yuan) to deal with the aftermath. Philips officially declared: The recall "will not have a significant impact on the company's revenue situation this year.
For those who are still using these devices, Philips officials have previously recommended that they stop using CPAP devices immediately and look for alternatives on the advice of their doctors.
As one of the three largest multinational medical device giants, Philips is actually a "big recaller".
Health Awareness Bureau statistics found that the State Drug Administration in the first half of this year issued 18 recall notices about Philips, the first level of recall 1 time, the second level of recall 12 times, the third level of recall 5 times.
Among them, the first class recalls medical devices that "may cause or have caused serious health hazards". According to the requirements of the State Drug Administration, companies need to make a recall decision within one day, notify the medical device business, the use of units, or inform the user.
Philips recalled products in the past six months, mainly related to home and medical ventilators, defibrillators / monitors, magnetic **** vibration imaging systems, etc., basically covering most of the categories of medical devices sold by Philips in the country .
At the end of March this year, High Tide Capital offered 3.7 billion euros to buy Philips' home appliance business. In the face of questions about why the outside world to sell the core business, Philips Global CEO Marriott said in an interview: Future, Philips will focus on the development of the field of health technology. Its determination to "focus on healthcare" is clearly visible.
After Marriott took over in 2011, he continued to merge and acquire, invest in reforming the Philips healthcare business, and also aspired to make Philips a "lion that hunts fast". Under his leadership, Philips in the competition with Siemens, GE Healthcare is not weak.
However, the unprecedented recall seems to have sounded the alarm.
Previously, analysts have pointed out that the active recall of medical devices does not mean that the company is in a serious medical malpractice storm, but frequent recalls will inevitably trigger the market on the production of Philips products, research and development, and even the management of the question , and then on the overall brand image of the impact.
In this recall, Philips' attitude is proactive and positive. Philips estimates that the entire recall will take up to a year and cost more than 3.9 billion dollars. After this, what Philips will face is still unknown. But there is no doubt that, even if it is aspiring to become a "lion" Philips, always have to start from the "fight lice" to do.
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#Ventilator # #Cancer #
#Ventilator # #Cancer #