In June, NMPA has released 14 recalls regarding the imported medical devices in China. The table below is a summary for the recalls of the overseas manufacturers. Since China NMPA enhances the post-market surveillance, Inspirative Medical can help manufacturers review all labels in compliance to China regulations.
For the specific model and batch of products, the fasteners of the previous cooling unit were used when replacing the cooling unit (CLU), which resulted in a CLU being removed from the fixed position of CT scanning frame
Gambro Dialysatoren GmbH
Polyflux H
II
For the specific model and batch of products, users find that there are suspected “particles” in the products before use.
Smith & Nephew, Inc.
Total Knee System-Oxinium femoral implant
II
The surface damage of specific model and batch of products is caused by manufacturing errors.
DePuy International Limited
Femoral Head
III
The etched model and size information of specific model or batch of products are inconsistent with the real object.
Philips Medical Systems Nederland B.V.
Magnetic Resonance Equipment
II
For the specific model or batch of products, the diameter of the bolt interface required for the rotary ring bolt used to lift the hardware does not meet the requirements.
Arrow International, Inc.
Intra-Aortic Balloon (IAB) Catheter Kit
III
Products of specific models and batches are not approved for marketing but sold in relevant regions.
Edwards Lifesciences LLC
Venous/Arterial Blood Management Protection System & Disposable Pressure Transducer
II
The pressure transmission pipeline of specific model and batch products falls off.
8. EUROSILICONE S.A.S.
Mammary Implantable Paragel
I
For the specific model and batch of products, textured implants may be associated with a high risk of ALCL.
Biomet Orthopedics
Arcos Modular Revision System
III
For the specific model and batch of products, there are chatter marks on the inner cone surface of the product due to the mismatching of boring bar in the manufacturing process.
Nobel Biocare AB
Nobel Procera Dental Ceramics
II
One sintering furnace used for production in March 2021 does not reach the proper sintering curve
Philips Medical Systems(Cleveland), Inc
PET/CT Imaging System
III
For the specific model and batch of products, failure to identify the serious wear of the monitor bracket assembly shaft may cause the monitor bracket assembly to fall off from the suspension arm.
Stryker Medical
Electrical Hospital Beds
III
The recalled products are suitable for clinical institutions, but not for personal use in the family environment. This recall involves the national sale of products to individual users, which is beyond the scope of application.
Philips Medical Systems Nederland B.V.
Computed Tomography System
III
For the specific model and batch of products, Synchright p3t (personalized patient protocol) software will increase the contrast dose when the patient’s weight unit is set to pounds.
Ethicon Endo-Surgery,LLC
Linear Cutter 55/75mm and Selectable Cartridge/reloads
III
For the specific model and batch of products, there is incompatibility between linear Cutter 55/75mm and Selectable Cartridge/reloads in the package.
