State Drug Administration: A number of arms enterprises recall a total of 32,000 products

Pharmaceutical Network October 29 - China 22 October 26, according to the State Drug Administration, Philips Medical (Suzhou) Co., Ltd. reported that the enterprise in internal testing found that its production of mobile digital medical x-ray photography system (product model: MobileDiagnost wDR) did not paste 2 categories Chinese laser description label, is now actively recalled, recall level three.
from the State Administration of Drug Administration issued in 2017 "Medical Device Recall Management Measures" can be seen, according to the severity of medical device defects, medical device recalls are divided into three levels.
The Measures stipulate that if a medical device manufacturer determines that a medical device product is defective, it shall immediately decide and implement the recall, and at the same time issue the product recall information to the society.
If the use of the medical device may or may have caused serious health hazards, a first-level recall is implemented; if a temporary or reversible health hazard may or may have been caused, a second-level recall is implemented; and if the likelihood of causing harm is small but still needs to be recalled, a third-level recall is implemented.
the implementation of a first-level recall, the recall notice shall be published on the website of the State Drug Administration and the central major media, and the second- and third-level recall announcement shall be published on the website of the provincial food and drug regulatory department.
After a medical device manufacturer has made a decision to recall, the first, second and third-level recalls shall be notified to the relevant medical device operating enterprises, users or users within 1, 3 and 7 days, respectively.
China 109 Cherry Blossom Medical Technology (Taizhou) Co., Ltd. reported that due to software defects, in the ozone processing process failure alarm, after the cancellation of the fault alarm, the window may be unlocked, is now the frozen slicer to implement an active recall, the recall level is level two.
32,340 Yong city science and technology testing plants in China reported that according to the State Drug Administration flight inspection found problems, enterprises in accordance with the requirements to assess the safety risks of medical glue products, there may be safety risks of products for active recall.
recall level is level three.
the medical device recall report form for details such as the model, specifications and batch of the product.