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On August 25, the State Food and Drug Administration issued an announcement to notify 4 device companies of their voluntary recalls of some of their products in violation of regulations
.
Including color ultrasound diagnosis system, electronic bronchoscope and so on
Details are as follows:
Philips Ultrasound, Inc.
voluntarily recalls Diagnostic Ultrasound System and Transducers
voluntarily recalls Diagnostic Ultrasound System and Transducers
Philips (China) Investment Co.
, Ltd.
reported that due to software defects related to specific models and batches of products, the EPIQ and EPIQAFFINITI ultrasound systems may not respond (lock) when reviewing or adjusting the xPlane inspection results, preventing users from continuing to perform clinical trials For the problem of use, Philips Ultrasound, Inc.
, the manufacturer of Philips Ultrasound, Inc.
, gave the color ultrasound diagnostic system Diagnostic Ultrasound System and Transducers (registration number: National Machinery Injection 20193062262, National Machinery Injection into 20183230036, National Machinery Injection into 20213060175, China National Machinery Injection 20193061914, National Machinery Injection 20193061919, National Machinery Injection 20203060422, National Machinery Injection 20153231350, National Machinery Injection 20153061349) Actively recalled
.
The recall level is level two
The recall level is level two
Medical Device Recall Event Report Form
Olympus Medical Co.
, Ltd.
actively recalls electronic bronchoscopes
, Ltd.
actively recalls electronic bronchoscopes
Olympus (Shanghai) Co.
, Ltd.
reported that during the production process of the electronic bronchoscope BF-XT160, there is no adhesive between the endoscope tube and the tip of the insertion part, and the production of the repair component (NS component) of the BF-XF160 is also With the same problem, the manufacturer Olympus Medical Co.
, Ltd.
voluntarily recalled the electronic bronchoscope (registration number: National Food and Drug Administration (Jin) 2006 No.
3220262)
.
The recall level is level two
The recall level is level two
Medical Device Recall Event Report Form
Braun Medical Spain Joint Stock Company B.
Braun Surgical SA voluntarily recalls Monosyn Synthetic absorbable surgical suture
Braun Surgical SA voluntarily recalls Monosyn Synthetic absorbable surgical suture
Braun Medical (Shanghai) International Trade Co.
, Ltd.
reported that due to specific models and batches of products, there was a problem that foam or glue residues were found on the suture needles after being taken out of the package.
Braun Medical Spain Joint Stock Company B.
Braun Surgical SA has voluntarily recalled Monosyn Synthetic absorbable surgical suture (Registration Certificate No.
: National Instruments Injection 20193021757, National Food and Drug Administration (Jin) Zi 2014 No.
3652889)
.
The recall level is level two
The recall level is level two
Medical Device Recall Event Report Form
GS Elektromedizinische Gerate G.
Stemple GmbH actively recalls Defibrillator/Monitor, a defibrillation monitoring system
Stemple GmbH actively recalls Defibrillator/Monitor, a defibrillation monitoring system
US-China Mutual Benefit (Beijing) International Trade Co.
, Ltd.
reported that due to specific models and specific batches of products, there is a drop from a height outside the specified range.
A specific batch of corpuls3SLIM defibrillation and pacing unit (equipment number 04301) is extremely rare The manufacturer GS Elektromedizinische Gerate G.
Stemple GmbH has voluntarily recalled the Defibrillator/Monitor (registration certificate number: National Machinery Injection 20163212364)
.
The recall level is three
The recall level is three
Medical Device Recall Event Report Form
