January a total of 108 medical device recall | domestic and foreign giants in the column
According to CFDA official website shows that in January 2018, a total of 108 medical device recall!
Domestic and foreign giants in the column, Roche 3 two
Recalls involving the Siemens, Philips, GM, Roche, Mindray, Enpu and other giants at home and abroad.
Siemens: 3, including 2 diagnostic products (three) and a photographic equipment (three);
Philips: 2, including 1 photographic equipment (level 3) and 1 electron emission system (level 3);
General: 1, anesthesia machine (two);
Roche: 3, immune analyzer (two);
Mindray: 1, assay kit (three);
Enpu: 1, Doppler ultrasound system (three)
...
6 causes 'sampling failed to pass' recall
Since 2017, the state regulatory authorities have been working on medical equipment enterprise Of the flying inspection was significantly increased.From the flying inspection of the degree of refinement and the number of objects were significantly improved over the previous year.Recall data in January showed that nearly every 6 recalls, there is 1 because of the "sampling failed" Sampling failed rate of 15%.
Medical equipment recall the most
Among the 108 recalls, the device-based medical device accounted for more than 50 seats, the largest number being clinical platform products such as therapeutic devices and oxygen generators, and a large number of imaging and radiological systems.
Schedule, January 2018 Medical Device Recall Schedule
sequence
Manufacturer
product name
Recall level
Recall reason
1
Shijiazhuang Kangan medical equipment
Medical surgical mask
Three levels
Sampling failed
2
Anhui Jinjianqiao Medical Technology
Breast treatment instrument
Three levels
Internal management
3
Beckman Coulter Business (China)
Many biochemical calibrators
Three levels
The test result is wrong
4
Dräger Medical Equipment (Shanghai)
Anesthesia machine, anesthesia system
Three levels
Improper use of the user
5
Heng Jia medical equipment trade (Shanghai)
Spiral tomography radiotherapy system, spiral CT and radiotherapy system
