Inventory of AE and Recalls in August

2021-09-03

In August, NMPA has released 28 medical device recalls, 14 of which are imported products.

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. Click the link below for interpretation of PMS/QMS in China: [Webinar] China Modified MDR (Order 739) Has Arrived— Opportunity knocks: Quality Management System, Design Control, Post-Market Surveillance | Inspirative Medical

Manufacturer	Product Name	Recall Classification	Recall Reason
Life Technologies Holdings Pte Ltd	Genetic Analyzer	III	A small part of 3500Dx Genetic Analyzer contains the wrong and expired medical device registration certificate number on the Chinese label of the product.
William A.Cook Australia, Pty. Ltd.	Benchtop Incubator	III	There is a translation error in the Italian and Swedish language of the product.
Roche Diagnostics GmbH	Accu-Chek Aviva test strips	II	There is a concern that the cartridge in the sealed box may have been accidentally opened during shipping.
Merit Medical Systems, Inc.	Introducers & Accessories	III	The product contains incorrect dilator.
Elekta, Inc.	Radiation Treatment Planning System	III	Some earlier versions of the product may have calculation problems in specific usage scenarios.
Philips Medical Systems Nederland B.V.	Magnetic Resonance Equipment	III	Philips detected a problem with the pressure reducing valve in the magnet assembly of the product involved. A 3.75 psi pressure reducing valve should be installed, but the affected equipment installed a 42 psi pressure reducing valve.
Boston Scientific Corporation	Percuflex Plus Ureteral Stent	III	The fixation strength of ureteral stent does not meet the product technical requirements (PTR) due to literal error in the PTR.
Beckman Coulter Biomedical GmbH	DxA Automation System	III	It was found that the sample trolley with or without samples was transported to the outer passage of the single drive transportation section and reached the end of the passage, then dropped from the passage. According to the DXA system design specification, the outer passage is not expected to be used to transport test tubes, so there is no physical barrier at the end to physically limit the sample trolley.
Micro Therapeutics, Inc. DBA ev3 Neurovascular	Pipeline Flex Embolization Device	II	The spiral cutting area of sea wave tube is broken due to the defect of raw materials in a specific batch. These fractures can lead to device failure and, in some cases, adverse events.
Immunotech SAS, A Beckman Coulter Company	Access hsTnI	II	The use of Access hsTnI may cause problems such as carryover.
11. GS Elektromedizinische Gerate G. Stemple GmbH	Defibrillator/Monitor	III	When the product falls from a height outside the specified range, the specific batch of corpuls3slim defibrillation pacing unit (equipment No. 04301) may fail to start treatment due to impact in rare cases.
B.Braun Surgical SA	Monosyn Synthetic absorbable surgical suture	II	There is foam or glue residue on the suture needle when a specific type or specific batch product is removed from the packaging.
Olympus	Electronic bronchoscope	II	Since there is no adhesive between the endoscope tube and the tip of inserting part during the production of electronic bronchoscope BF-XT160.
Philips Ultrasound, Inc.	Diagnostic Ultrasound System and Transducers	II	Due to software defects, EPIQ and epiqaffiniti ultrasound systems may not respond (lock) when reviewing or adjusting xPlane inspection results, preventing users from continuing clinical use.