On October 12, the Shanghai Food and Drug Administration issued 23 reports of medical device recalls.
They are as follows:
1. Mai Kewei: Mobile operating table
Mai Kewei (Shanghai) Medical Equipment Co., Ltd. reported that the company found that the poor square welding may cause damage between the square hole of the operating room accessory adapter and the first joint, which may cause serious injury to the patient. The company decided to recall the relevant products, this recall level II.
Areas and countries involved: global.
The number of sales in China: 62 units.
2, Mai Ke Wei: medical physical temperature meter and artificial heart-lung machine - heat exchange water tank
Mai Kewei (Shanghai) Medical Equipment Co., Ltd. reported that the company found mycobacterial contamination (and other bacterial contamination) in the water of the artificial heart-lung machine-heat exchange water tank. The company decided to recall the product and notify relevant customers to take corrective measures. And the timing of the release of the new disinfection process by the manufacturer. This recall level is Level III.
Areas and countries involved: global.
The number of sales in China: 418 units.
3, Bangmei: modular full knee system
Bangmei (Shanghai) Trading Co., Ltd. report: The company survey found that the drill bit used for the hexagonal hole drilling of the bolt head may be larger than the acceptable allowable value of the tolerance, which may result in the bolt not being fully tightened. The company decided to recall the relevant products, this recall level II.
Regions and countries involved: the United States, Europe, the Middle East and the Asia Pacific region.
The number of products involved in production (or importing China): 159 pieces.
Number of sales in China: 0 pieces.
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4, GE: baby warmth
General Electric Medical Systems Trade Development (Shanghai) Co., Ltd. report: The company found that the screws involved in the heating part of the product are at risk of loosening. If the radiant heating part is not properly maintained, the hot screws may fall onto the mattress and contact. There are risks to the patient. The company decided to recall the relevant products, this recall level II.
Areas and countries involved: the United States, Australia, Canada, China and other countries and regions.
Sales in China: 254.
5. GE: Magnetic Resonance Imaging System
General Electric Medical Systems Trade Development (Shanghai) Co., Ltd. Report: The company received a recall notice from the CADStream component supplier, and the product SureLoc function and PURE function are defective. The company decided to recall the relevant products, this recall level II.
Areas and countries involved: Australia, China and other countries and regions.
Number of sales in China: 34.
6, Medtronic: argon-enhanced electrosurgical system, electrosurgical instruments
Medtronic (Shanghai) Management Co., Ltd. reported that the company found that there were seal defects in the inner packaging of the product, and there was a possibility that the sterile barrier was destroyed, which increased the risk of infection. The company decided to recall the relevant products and recycle all unused products. This recall level is Level II.
Areas and countries involved: global.
The number of sales in China: 103 boxes.
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