NMPA Issues Recalls for Fujifilm and Carl Zeiss Medical Devices

Since the beginning of the year, the National Medical Products Administration has issued multiple medical device recall notices,

February 21,FUJIFILM Wako Pure Chemical Corporation Initiates Voluntary Recall of Abnormal Prothrombin Measurement Kit (Immunofluorescence Method)。

Fujifilm Wako Pure Chemical (Shanghai) Co., Ltd. reported that due toProducts with specific batch numbers tend to have higher measurement values for samples in low-concentration areas.Due to reasons, the manufacturer FUJIFILM Wako Pure Chemical Corporation has voluntarily recalled its produced Abnormal Prothrombin Measurement Kit (Immunofluorescence Method) μTASWako PIVKAⅡ (China Medical Device Registration No. 20163402602). The recall level isLevel 2 Recall. For specific model, specifications, and batch details, please refer to the "Medical Device Recall Incident Report Form".

Attachment: Medical Device Recall Event Report Form

On the same day,Carl Zeiss Meditec AG (Germany) voluntarily recalls surgical microscopes and ophthalmic navigation surgical microscopes.

Carl Zeiss Shanghai Co., Ltd. reported that due toWhen the product is equipped with OCT function, UDI traceability can only be performed through manual reports.Due to reasons, the manufacturer Carl Zeiss Meditec AG (Germany) has voluntarily recalled its Surgical Microscope (Registration No. 20192162224) and Ophthalmic Navigation Surgical Microscope (Registration No. 20223160461). The recall level isLevel 3 Recall. The products involved in this recall were not imported into China. For detailed information such as specific models, specifications, and batches, please refer to the "Medical Device Recall Event Report Form."

Attachment: Medical Device Recall Event Report Form

January 13,WEINMANN Emergency Medical Technology GmbH + Co.KG Initiates Voluntary Recall of Ventilators

Vimann (Shanghai) Medical Device Trading Co., Ltd. reported that due toThe device may recognize high-frequency air flow as "pseudo-breathing," thereby affecting the accuracy of etCO2 measurement.Due to reasons, the manufacturer WEINMANN Emergency Medical Technology GmbH + Co.KG voluntarily recalled its ventilator (Registration No. 20153081989 of Imported Medical Device into China). The products involved in this recall were not imported into China. For specific model, specifications, batch number and other detailed information, please refer to the "Medical Device Recall Event Report".

Attachment: Medical Device Recall Incident Report Form

January 13,MicroVention Europe SARL, a subsidiary of 美科微先欧洲有限公司, initiates a voluntary recall of intracranial stent systems.

Beijing MicroVention Medical Technology Co., Ltd. reported that due to the PTFE (polytetrafluoroethylene) material wrapping the stent ring, which hindered the stent from being pushed out of the delivery catheter (in-package introducer sheath), the manufacturer MicroVention Europe SARL initiated a voluntary recall of its intracranial stent system LVIS Intraluminal Support Device (China Medical Device Registration No. 20213130513). The recall level isLevel 1 Recall. For detailed information such as product model, specifications, and batch numbers, please refer to the "Medical Device Recall Event Report Form."

Attachment: Medical Device Recall Event Report Form