For Philips, the past week has not been calm.
First, on June 14, local time, the website of Forbes magazine said that Philips was about to recall as many as 4 million ventilators, mainly because a foam material used in these devices might degrade and release harmful and possibly carcinogenic substances.
A few days later, on June 17, China State Medical and Drug Administration issued two consecutive notices, announcing the recall of 28,494 non-invasive ventilators and X-ray computed tomography equipment owned by Philips. Among them, the number of ventilator products sold in China is as high as 28,450. The main reason for the recall is that the foam materials used in the equipment may endanger human health.
The Health Bureau found that in the first half of this year alone, the National Medical Products Administration issued 18 recall notices related to Philips, involving more than 654.38+million sets of ventilators, imaging equipment, monitors and other products.
"Polyester polyurethane", Philips' domino was knocked down by it.
According to public information, the PE-PUR anechoic foam used in these breathing equipment will degrade particulate matter under certain conditions, which may cause headache, irritation, nausea, vomiting and even potential carcinogenicity. But so far, officials have not received any reports of deaths caused by this equipment.
Earlier, Steve klinck, the official spokesman of Philips, said in an interview with Reuters that "80% of the affected devices in the recall list are CPAP ventilators used by patients with sleep apnea". The device is mainly used to treat sleep apnea syndrome, that is, apnea caused by snoring.
CPAP ventilator is a kind of continuous positive airway pressure ventilator, and there is also a BiPAP ventilator with bi-level positive airway pressure ventilation. Up to now, Philips has produced millions of BiPAP, CPAP and mechanical ventilators, all of which have PE-PUR silencing foam. The data shows that in 2020, the complaint rate of users to these devices is only about 0.03%, but Philips still decided to take the initiative to recall.
In China, Philips also began to recall related products. On June 17, the State Administration of Medical Supplies issued a notice saying that Weikang Medical Supplies (Shenzhen) Co., Ltd. announced the recall of more than 20,000 non-invasive breathing equipment with the model of DOMA 500 Auto, which was also caused by PE-PUR silencing foam. Wellcome Medical is one of Philips ventilator manufacturing bases in the Asia-Pacific region.
In response to this recall, Philips has allocated a total of 500 million euros (about 3.9 billion yuan) to deal with the aftermath. Philips officially declared that the recall "will not have a great impact on the company's revenue this year."
For those who are still using these devices, Philips officials have previously suggested: stop using CPAP devices immediately and find alternative users under the advice of doctors.
As one of the three multinational medical device giants, Philips is actually a "big recall".
According to the statistics of the Health Information Bureau, among the 18 Philips recall notices issued by the State Administration of Medical Supplies in the first half of this year, there were 1 for the first grade, 12 for the second grade and 5 for the third grade.
Among them, the first-level recall is aimed at medical devices that may or have caused serious health hazards. According to the requirements of the State Administration of Medical Products, enterprises need to inform the operating units or users of medical devices within 1 day after making the recall decision.
The products recalled by Philips in the past six months mainly involve household and medical ventilators, defibrillators/monitors and magnetic resonance imaging systems. , which basically covers most categories of medical devices sold by Philips in China.
At the end of March this year, Gaochun Capital offered 3.7 billion euros to acquire Philips' home appliance business. Facing the question of why the outside world sold its core business, Frans van Houten, global CEO of Philips, once said in an interview: In the future, the development focus of Philips will focus on the field of health technology. Its determination to "concentrate on medical care" is obvious.
Frans van Houten 20 1 1 took office, and constantly acquired and invested in the reform of Philips' medical business, once determined to turn Philips into a "lion that hunts in groups quickly". Under his leadership, Philips did not show weakness in the competition with Siemens and GE Medical.
However, the unprecedented large-scale recall seems to have sounded the alarm.
Earlier, some analysts pointed out that the voluntary recall of medical devices does not mean that the company is caught in a serious medical accident storm, but frequent recalls will inevitably lead to the market questioning the production, research and development, and even management of Philips products, thus affecting the overall brand image.
In this recall, Philips' attitude is positive and positive. Philips estimates that the entire recall will last for one year and cost more than 3.9 billion yuan. What kind of situation Philips will face after that is still unknown. But there is no doubt that even Philips, who is interested in becoming a "lion", always starts with "playing lice".
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# Ventilator # # Carcinogenic #