Philips Baitai Medical Devices Recall | Or Causes Severe Injury Risk From Leakage

On March 28th, March 26th, the State Food and Drug Administration issued a recall announcement for medical devices. The announcement stated that Philips Medical Co., Ltd. (hereinafter referred to as 'Philips Medical') reported that the demagnetization of magnets may cause leakage of hernia. The company voluntarily recalled its magnetic resonance imaging system and medical magnetic resonance imaging system, with a recall level of three. At the same time, it also disclosed the "Medical Device Recall Incident Report Form."

The report shows that the recalled product is suitable for clinical magnetic resonance imaging, covering the scope and even the world. It involves the product type Multiva 1.5T, the number of production (or imports into China) is 412 units, and the number of sales in China is 107 units. .

"Financial Mirror" (WeChat id: news_cj) noted that the reason for this recall was: In rare cases, the degaussing process of magnets, together with the blockage of helium gas discharge pipes, caused poor discharge and helium might enter the inspection room.

In fact, for Philips Medical, this recall is not the first occurrence.

It is reported that on August 30, 2016, the Philips Medical Report stated that Philips Medical (Suzhou) Co., Ltd. has produced a digital medical X-ray radiography system because of abnormalities in the internal firmware of the flat panel detector." Registration No.: Su Shi Food and Drug Administration Machinery (quasi) word 2014 No. 2300610 'active recall.

In June 2017, Philips Medical reported that due to the vertical tube assembly movement There may be cracking in the solder joints of the stent. Digital Medical X-ray Photography System produced by Philips Medical (Suzhou) Co., Ltd.' Registration No.: Su Shi Ye Yao Xu (2013) No. 2310215, Suzhou Food and Drug Administration (Quasi) Word No. 2301194, Su Sushi Pharmaceutical (prospective) word No. 2300610 2014 'active recall.

On November 28, 2017, the Philips Medical Report stated that due to the wrong labeling of the vertical photo frame, Philips Medical took the initiative to recall its digital medical X-ray photography system (registration number: USM 201620300868).

It is worth noting that there has been a helium leak on the Philips system. After investigation, it was found that the metal burst film components in the discharge pipe involved in this incident did not work properly. When the magnets were demagnetized, the helium gas failed to follow. The normal discharge of the discharge pipe may cause helium to enter the inspection room. If the personnel in the inspection room were not evacuated in time, there was a potential risk of death or serious injury (asphyxiation).