Recently, the National Medical Products Administration issued a product recall notice, stating that due to potential issues such as excessive helium pressure during magnetic loss and structural integrity failure of Panorama HFO system components, the manufacturer Philips has applied for an active recall of the medical magnetic resonance imaging system (Panorama HFO). The recall level is level one.
The "Medical Device Recall Event Report Form" released at the same time shows that Philips has initiated a proactive recall of the affected Panorama HFO system globally, involving a total of 3 units in China. As of now, there have been no reports of human injury caused by this issue.
According to the severity of medical device defects, the first level recall is the highest level. Regarding the proactive recall of medical magnetic resonance imaging systems (Panorama HFO) in China and the impact of the recall on the company, a reporter from Huaxia Times contacted Philips China (Investment) Co., Ltd. The person in charge of medical communication told our reporter that "there are some key details waiting for a response from relevant departments.". As of the time of publication, our reporter has not received a written response from Philips China.
Highest level recall
The announcement from the National Medical Products Administration shows that the registration certificate number of the medical magnetic resonance imaging system recalled by Philips this time is National Food and Drug Administration (Jin) Zi 2012 No. 3282359. A medical device industry insider told Huaxia Times that 2012 was the first registration year of the medical magnetic resonance imaging system, indicating that the production and launch of this Philips medical magnetic resonance imaging system was relatively early.
On November 23rd, Philips China's official website was the first to issue a notice regarding the active recall of medical magnetic resonance imaging systems. The announcement stated that Philips was informed of an incident where the structural integrity of the Panorama HFO system components failed due to an unexpected high pressure of helium gas during the process of dismantling the magnet. Therefore, Philips initiated a proactive recall of the affected Panorama HFO system, with a total of 3 affected products in China. So far, there have been no reports of human injury caused by this issue.
Philips China announced that it will issue a proactive recall notice to affected customers, guiding them to immediately stop using the affected Panorama HFO system and take corresponding measures to avoid the occurrence of this potential problem. Philips will arrange on-site service engineers to visit the affected customer site and conduct on-site inspections of the system (internal number FCO78100572). According to the relevant regulations of China's medical device recall regulations, as of now, Philips is sending proactive recall notification letters to affected customers.
According to a query by a reporter from the Huaxia Times on Philips China's official website, in 2023, Philips also proactively recalled affected product models such as medical angiography X-ray systems, X-ray computed tomography equipment, and portable color ultrasound diagnostic systems.
On the same day as the recall of the Panorama HFO medical magnetic resonance imaging system, Philips China also announced an active recall of the UNIQ FD20 medical angiography X-ray system, involving 2966 device serial numbers. The recall level is level three.
Previously, in September of this year, Philips also voluntarily recalled medical magnetic resonance imaging systems. The recall announcement states that Philips has discovered that the magnets in the MR system are equipped with four lifting pulleys, all located at the top of the magnets. These lifting pulleys are used to allow the crane to move magnets in or out during dismantling or relocation activities. A mechanical issue was detected on these lifting interface blocks at the top of the magnet. In the initial design of the lifting interface, the diameter of the bolt fastening interface surface required for the rotating lifting eye bolts used as lifting hardware did not meet the required specifications. This potential issue may only occur when using a crane to directly lift magnets during dismantling or relocation activities. To solve this problem, a gasket was designed and installed around the lifting interface boss, providing the required interface surface. Therefore, Philips initiated a proactive recall of the affected Ingenia Absorption S, with a total of 1 affected product in China. The recall level is Level 2 recall.
The proactive recall of Philips products mentioned above is not like a first level recall for the Panorama HFO medical magnetic resonance imaging system, so it did not attract much attention. Medical device recall is mainly classified based on the severity of medical device defects, with a first level recall being the highest level. The use of this medical device may or has already caused serious health hazards.
Respirator storm
As a leading global health technology enterprise, Philips is considered one of the "three giants" in medical devices, and its product recalls have also attracted attention, especially the recent controversy over ventilator recalls.
In June 2021, Philips announced that it would recall 4 million ventilators and "CPAP" respiratory equipment, because it was worried about the health problems caused by the noise reduction foam decomposition inside the equipment. In July, the FDA classified this foam problem as a first level problem, the most serious type. According to FDA's recall notice, if the foam used to eliminate the sound and vibration of the ventilator starts to decompose over time, it may cause users to inhale debris and untested chemicals, which may cause headache, external and internal irritation, asthma, nausea, toxicity or carcinogenic effect on kidney, liver and other organs.
Subsequently, the United States and Canada filed multiple class action lawsuits, and Philips began repairing and replacing the recalled equipment. However, in January 2022, the FDA expanded the scope of the first level recall to include Philips respiratory devices, and Philips conducted multiple respiratory device recalls in the following year.
The recall crisis of Philips ventilators has affected China. In June 2022, the National Medical Products Administration of China issued two consecutive notices, announcing the recall of a total of 28494 non-invasive ventilators and X-ray computed tomography equipment under Philips.
In November 2022, Philips notified the FDA that its refurbished Respironics Trilogy ventilator had two new potential issues. Philips announced that the ventilator model with potential issues was Trilogy 100/200, accounting for 3% of the initial 5.5 million respiratory devices recalled.
According to reports, in response to the ventilator recall incident, Philips has reserved approximately 1 billion euros (approximately 1.1 billion US dollars) for recalling approximately 5.5 million devices and agreed to pay at least 479 million US dollars in September to resolve some of the lawsuits.
The recall controversy has had a huge impact on Philips. According to Philips's 2021 performance report, the recall of multiple respiratory devices such as CPAP and BiPAP resulted in a net revenue loss of 719 million euros (approximately 5.048 billion RMB) for Philips in 2021. And this impact will continue until 2022. The financial report shows that Philips had a net loss of 1.605 billion euros in 2022, compared to a net profit of 3.323 billion euros in the same period last year; The operating income loss was 1.529 billion euros, compared to 553 million euros in the same period last year.
In November of this year, Philips faced new safety issues with its DreamStation 2 machine used to treat obstructive sleep apnea. According to media reports, the FDA recently warned that it has received reports of issues including fires, smoke, burns, and other signs of overheating while using the device. The FDA stressed that they believed that this problem was not related to the foam used in the DreamStation 2 machine.
Xiao Xiao, an independent commentator in the pharmaceutical industry, told a reporter from Huaxia Times that medical device recalls belong to the normal management of problematic devices. The production of medical device products cannot completely avoid some defects. Recalls are remedial measures taken through warning, inspection, repair, re labeling, modification and improvement of instructions, software updates, replacement, retrieval, and destruction. However, at the same time, production enterprises must also strictly control product quality and safety.