# China NMPA Product Recall - X-ray machine

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/a8a1dff6-6afc-435a-b18f-e637fb77333f/
Source feed: China

> China NMPA product recall for X-ray machine by Philips (China) Investment Co., Ltd. published January 13, 2021. Recall level: Level 2 Recall. Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall for its fluoroscopy X-ray

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. is voluntarily recalling X-ray machines (fluoroscopy X-ray machines).
- Company Name: Philips (China) Investment Co., Ltd.
- Publication Date: 2021-01-13
- Product Name: X-ray machine
- Recall Level: Level 2 Recall
- Recall Reason: 1. Under certain operating conditions, a malfunction in the automatic dose rate control (automatic exposure control - AEC) may cause the system to stabilize at a dose rate higher than necessary.
2. When the user selects a lock command, the kV and mA values are not immediately locked. If the collimator shutter position is changed immediately after the lock command, the kV and mA values may change. This will result in variations in technical factors.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips (China) Investment Co., Ltd.
- Summary: Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall for its fluoroscopy X-ray machines, specifically addressing issues with the ProxiDiagnost N90 system. This recall was officially reported on January 11, 2021, and published by the National Medical Products Administration (NMPA) on January 13, 2021, in collaboration with the Shanghai Municipal Drug Administration.

Two primary technical deficiencies prompted this action. Firstly, under specific operating conditions, the automatic dose rate control, or automatic exposure control (AEC), was found to malfunction. This flaw could cause the system to maintain a radiation dose rate higher than clinically required, potentially impacting patient safety. Secondly, the system exhibited a delayed response to the user's "lock command" for kV and mA values. If the collimator shutter position was adjusted immediately after issuing the lock command, the kV and mA settings could inadvertently change. This alteration in technical factors could affect the accuracy and consistency of the fluoroscopy examination, only being rectified if the user stopped and restarted the X-ray fluoroscopy procedure.

In response to these identified concerns, Philips (China) Investment Co., Ltd. is undertaking a voluntary recall. The Class II classification indicates that the product may cause temporary or reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. The company is required to provide comprehensive details regarding the specific models, specifications, and affected product batches through a "Medical Device Recall Event Report Form." This action ensures compliance with national medical device regulations and aims to mitigate potential risks to patients and healthcare professionals.

Company: https://www.globalkeysolutions.net/companies/philips-china-investment-co-ltd/65759337-23bf-4cad-9163-71c3b842aa8b/