Machinery / Industrial Parts & Tools

On August 3, the State Food and Drug Administration issued an announcement to notify the four device companies of Elekta, Meritone, Roche Diagnostics, and Cook that they have actively recalled some of their products in violation of regulations.

These include radiation therapy planning software, catheter sheath equipment, blood glucose test strips, and desktop incubators.

Details are as follows:

Elekta (U.S.) company Elekta, Inc. voluntarily recalled Radiation Treatment Planning System

Elekta (Shanghai) Medical Equipment Co., Ltd. reported that due to specific models and batches of products, some early versions of the products may have calculation problems in certain usage scenarios. The manufacturer Elekta (USA), Inc. . Actively recall the radiation treatment planning software Radiation Treatment Planning System (Registration Certificate No.: National Machinery Injection 20153210147). The recall level is three.

Merit Medical Systems, Inc. voluntarily recalled Introducers&Accessories for catheter sheath equipment

Merit Medical Devices (Beijing) Co., Ltd. reported that the product contains incorrect expanders due to specific models and batches of products. The manufacturer Merit Medical Systems, Inc. of the United States is right. Introducers&Accessories (Registration Certificate No.: National Machinery Injection 20153032590) for catheter sheath equipment was voluntarily recalled. The recall level is three.

Roche Diagnostics GmbH voluntarily recalled Accu-Chek Aviva test strips (glucose dehydrogenase method)

Roche Diagnostics (Shanghai) Co., Ltd. reported that due to specific models and batches of products, the test strip tube in the sealed box may be accidentally opened during transportation. The manufacturer Roche Diagnostics GmbH Dehydrogenase method) Accu-Chek Aviva test strips (Registration Certificate No.: National Machinery Injection 20162403050) was voluntarily recalled. The recall level is level two.

William A. Cook Australia, Pty. Ltd actively recalls Benchtop Incubator

Cook (China) Medical Trading Co., Ltd. reported that due to specific models and batches of products, there was a problem with a translation error in the Italian and Swedish language of the product manual. The manufacturer, William A. Cook Australia, Pty. Ltd actively recalled Benchtop Incubator (Registration Certificate No.: National Machinery Injection 20162185127). The recall level is three.