Roche Diagnostics and Medtronic Initiate Class II Recalls of Specific Medical Devices in China

On November 16, the National Medical Products Administration (NMPA) issued an announcement, notifying that GE Healthcare, Medtronic, and Roche Diagnostics had voluntarily recalled some of their non-compliant products. These include whole-body X-ray computed tomography systems, disposable blade heads, and myoglobin test kits.

The specific situation is as follows:

GE Medical Systems, LLC, a subsidiary of GE Healthcare, voluntarily recalls products including the whole-body X-ray computed tomography system.

General Electric Medical Systems Trade Development (Shanghai) Co., Ltd. reported that due to issues involving specific models and specific batches of products, there may be a problem of displaying incorrect dosage during interventional surgery when using the SmartStep option. The manufacturer, GE Medical Systems, LLC, is voluntarily recalling products such as the whole-body X-ray computed tomography system (registration certificate number: GuoXieZhuJin 20143065741).Recall level is Level II.

Attachment:Medical Device Recall Incident Report Form

Medtronic Xomed, Inc. Voluntarily Recalls Disposable Blades and Other Products

Medtronic (Shanghai) Management Co., Ltd. reported that due to issues involving specific models and specific batches of products, there has been an increase in complaints related to tip breakage and oscillation/vibration. The manufacturer, Medtronic Xomed, Inc. based in the USA, is voluntarily recalling products such as disposable blades (registration certificate number: GuoXieZhuJin 20162042506).Recall level is Level 2.

Attachment:Medical Device Recall Incident Report Form

Roche Diagnostics GmbH Initiates Voluntary Recall of Tina-quant Myoglobin Gen.2 (MYO2) Assay Kit (Immunoturbidimetric Method)

Roche Diagnostics Products (Shanghai) Co., Ltd. reported that due to issues involving specific models and specific batches of products, there is a problem with negative bias in quality control and monitoring results for the Myoglobin assay on the cobas c 503 platform. The manufacturer, Roche Diagnostics GmbH, is voluntarily recalling the Myoglobin assay kit (immunoturbidimetric method) Tina-quant Myoglobin Gen.2 (MYO2) (registration certificate number: National Medical Device Registration No. 20162400540).Recall level is Level II.

Attachment:Medical Device Recall Incident Report Form