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Named by NMPA: Siemens and Poco International recurred a large number of recalls!

2021-07-28

On July 22, the NMPA issued recall announcements, and a large number of medical products were recalled due to problems.

The recalled products include level 1 recall and level 2 recalls. The products involved are Diagnostic Ultrasound System from Siemens Medical Solutions USA, Inc., Aorta Molding Balloon Catheter from Gore & Tongren Co., Ltd., and the implantable cardiac resynchronization therapy pacemaker from Poco International Medical Trading (Shanghai) Co., Ltd.,etc.

 

Details of the recall of all the above products:

Company Reason for Recall Result
Poco International Medical Trading (Shanghai) Co., Ltd.

 

Poco International Medical Trading (Shanghai) Co., Ltd. reports that due to the problems in the late life of the device (for example, before the battery replacement indication is reached) involving specific models and specific batches of products, the device may switch to a safe mode when the internal impedance of the battery is too high and the program control inquiry is attempted. This potential battery condition puts the device at risk for system reset. Poco International Medical Trade (Shanghai) Co., Ltd. voluntarily recalled implantable cardiac resynchronization pacemakers and other products. Related product recall information was  released on June 7, 2021, and the recall level is level 2,and now is changed to Level 1.

 

Gore Industrial Products Trading (Shanghai) Co., Ltd. Gore Industrial Products Trading (Shanghai) Co., Ltd. reports that there may be problems with inadequate or non-filling of the balloon due to pre-preparation testing or leakage of the tail bonding port of the guide wire cavity and Y-joint during the use of the product involving a specific model and batch of the product. The manufacturer Gore & Tongren Co., Ltd. voluntarily recalled the Molding Balloon Catheter with level 2 recall.

 

Siemens Medical Solutions USA, Inc. Siemens Medical Solutions USA, Inc.reports that due to specific models and batches of products, there may be a potential problem that some of the involved systems with installed battery packs are not connected to an external power source and cannot start the equipment normally. Siemens Medical Solutions USA, Inc. voluntarily recalled the Diagnostic Ultrasound System  The recall level is level 2.

 

 

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