Seven Recalls Released by NMPA

2020-12-02

On November 23, 2020, seven overseas manufacturers voluntarily recalled seven different medical devices. The recalls are Class II and III Recalls. Detailed information about the manufacturers and recalled products are listed in the table below. For more information about the recall products, please contact us via info@inspirativemed.com. Since China NMPA enhances the post-market surveillance, Bradynuoen can lead manufacturers in compliance with China regulations.

Manufacturer	Product Name	Recall Classification	Recall Reason
GE MEDICAL SYSTEMS, LLC	Computed tomography x-ray system	Class II	Part of the Revolution Apex system presents a potential central black spot artifact
Bard Peripheral Vascular, Inc.	PTA Balloon Dilatation Catheter	Class III	Product packaging error
Stryker Neurovascular	Trevo XP ProVue Retriever	Class II	Complaints on the core wire fracture of the bolting support has increased
BioMerieux, SA	VIDAS FT4 (FT4N)	Class III	The RFV signal value has a deviation beyond expectation
Becton Dickinson Infusion Therapy Systems, Inc.	BD NexivaTM Colsed IV Catheter System	Class III	There may be a “blunt needle” problem
Abbott GmbH & Co. KG	ARCHITECT EBV VCA IgM Calibrator	Class III	The RLU signal is reduced, eventually causing an error to be reported
MAKO Surgical Corp.	Robotic Arm Interactive Orthopedic System	Class II	Software error output