The State Drug Administration announced!These 26 batches of medical equipment are unqualified

The State Drug Administration today issued a notice for the results of the national medical device supervision and random inspection. The notice pointed out that the State Drug Administration organized a product quality supervision and random inspection of 12 varieties including electric wheelchairs, and found that 26 batches of (Taiwan) products did not meet the standards.

1. Medical device products that are not complied with the standards stipulated in the sampling items

(1) 3 electric wheelchairs: produced by Linyi Boyu Electric Car Co., Ltd., Tianjin Zhongbang Rehabilitation Equipment Co., Ltd., Tianjin Xitai Medical Device Co., Ltd. Horizontal pavement braking and maximum security slope braking do not meet the standards.

(2) 1 air belly machine: Beijing Fanxing Optoelectronics Medical Equipment Co., Ltd. produced, involving continuous leakage currents at normal operating temperature does not meet the standards.

(3) 1 batch of metal spine rods: Medialssey Co., Micdise Co., Ltd., Micadissey Co., Ltd.

(4) 1 batch of metal bone panels: SANATMETAL ORTHOPAEDIC Traumatologic Equipment Manufacturer LTD Hungarian Sono Mono Co., Ltd. involved in the bending strength and equivalent bending stiffness.

(5) ND: YAG laser therapy machine: produced by Wuhan Jinglier Laser Equipment Co., Ltd., involving the accuracy of control devices and instruments, laser terminal pulse energy/pulse string energy does not meet the standards.

(6) 1 gynecological ultrasonic diagnosis equipment: Produced by Wuxi Belson Image Technology Co., Ltd., involving the detection depth of the Doppler model, and the blood flow rate error is not in line with the standards.

(7) 1 portable X -ray machine: Qingdao Zhonglian Hainuo Medical Technology Co., Ltd. produced, involving the input power, the semi -price layer of the X -ray equipment, the focus to the skin distance of the skin.

(8) One dental planting machine: Foshan Dengtong Medical Device Co., Ltd. is produced, involving the air load speed does not meet the standards.

(9) 3 batches of one -time use of abdominal puncture device: produced by Hangzhou Tonglu Medical Optical Instrument Co., Ltd., Zhengzhou Kangshengjiutai Medical Equipment Co., Ltd., Jiangsu Feng and Medical Equipment Co., Ltd. Coordination performance does not meet the standards.

(10) 3 batches of surgery clothes: produced by Nanchang Yongdeli Medical Device Co., Ltd., Nanchang Donghai Medical Equipment Co., Ltd., and Chenghai District, Chenghai District, Shantou City, involved in swelling and piercing strong-dry state (product key key Regional), swelling strong-dry state (product non-critical areas), swelling strong-wet state (key area of ​​product), fracture strong-dry state (key area), fracture strength-dry state (product non-critical areas) , Fracture powerful-wet state (key areas of product), blocking microorganisms-dry state (product non-critical areas) do not meet the standards.

(11) 3 batches of the use of human venous blood sample collecting containers at one time: produced by Zhengzhou Tai Lili Medical Device Co., Ltd., Shijiazhuang Kangwei Shi Penalty Medical Device Co., Ltd. standard regulation.

(12) 7 cold -light sources: Nanchang Walker Medical Technology Co., Ltd., Tonglu Hongyi Medical Device Co., Ltd., Hangzhou Kangyou Medical Equipment Co., Ltd., Tonglu Boyi Medical Device Co., Ltd., Nanjing Meichun Medical Co., Ltd. The production of Hefei Deming Electronics Co., Ltd. and Tianjin Bulang Technology Development Co., Ltd. involved continuous leakage current, input power, and samples at normal operating temperature. Comply with standards.

2. For the above -mentioned products that do not meet the standards of standards, the State Drug Administration has requested that the provincial drug supervision and management department of the medical device registrar is located in accordance with the "Regulations on the Supervision and Administration of Medical Device", "Measures for Medical Device Production Supervision and Management", "Medical Device Recall Administration Measures 》 The requirements of the administrative processing decision in a timely manner and announced to the society. Provincial drug supervision and management departments should urge medical device registrars to evaluate risk assessment of products that do not meet the standards of random inspection, determine the recall level according to the severity of medical device defects, actively recall the product and publicly recall information; The reasons for qualifying, formulate rectification measures and rectify on time.

(Source: CCTV News Client)

【Edit: Wang Yujin】

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