According to the website of the State Food and Drug Administration, Philips Medical (Suzhou) Co., Ltd. issued a report saying that Philips Medical (Suzhou) Co., Ltd. due to the hydrogen embrittlement of the fasteners, the lack of strength of the outer shell material, cracking and image artifacts. The company actively recalled a number of X-ray computed tomography equipment produced by it, and recalled 52 devices in China.
According to the report, due to the hydrogen embrittlement of fasteners, etc., Philips Medical (Suzhou) Co., Ltd. produced X-ray computed tomography equipment [Registration No.: National Food and Drug Administration (quasi) word 2013 No. 3301488, country Food and Drug Administration (quasi) (2014 No. 3300672) took the initiative to recall 30 pieces of equipment in China.
According to the report, the X-ray computed tomography equipment produced by Philips Medical (Suzhou) Co., Ltd. due to insufficient strength of the outer casing material, etc. [Registration No.: National Food and Drug Administration (quasi) word 2013 No. 3301488, country Food and Drug Administration (quasi) word 2014 No. 3300672] took the initiative to recall, and involved 16 equipment in China.
In addition, due to image artifacts and other reasons, Philips Medical (Suzhou) Co., Ltd. produced X-ray computed tomography equipment [Registration No.: National Food and Drug Administration (quasi) word 2013 No. 3300671, National Food and Drug Administration ( Quasi-) 2014 No. 3300672] Proactive recall, involving 6 devices in China.
The product recall level involved in this time is three. Detailed information on the model, specifications and batches of the products can be found in the Medical Device Recall Report Form.
Attachment: Medical Device Recall Event Report Form
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