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.
