# China NMPA Product Recall - Medical angiography X-ray machine

Source: https://www.globalkeysolutions.net/records/china_product_recall/siemens-healthineers-co-ltd/eb626e7f-8a82-450a-bc95-05ceb3829ad2/
Source feed: China

> China NMPA product recall for Medical angiography X-ray machine by Siemens Healthineers Co., Ltd. published December 17, 2020. Recall level: Level 2 Recall. On December 17, 2020, Siemens Healthineers initiated a voluntary Class II recall for several models 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Siemens Healthineers Ltd. is voluntarily recalling its medical angiography X-ray machines.
- Company Name: Siemens Healthineers Co., Ltd.
- Publication Date: 2020-12-17
- Product Name: Medical angiography X-ray machine
- Recall Level: Level 2 Recall
- Recall Reason: A very small number of Artis zee/Q/Q.zen systems equipped with Siemens Tilt/Step (OR) inspection beds and software version VD11E have a potential issue: the safety limit switch is in the default activated state before the inspection bed reaches its destination. If the safety limit switch malfunctions, there is a minor possibility that the inspection bed movement may be obstructed or restricted, causing the system to execute a safety stop, requiring reactivation by a field service engineer.
- Discovering Company: Siemens Healthineers Co., Ltd.
- Manufacturing Company: Siemens Healthineers Co., Ltd.
- Summary: On December 17, 2020, Siemens Healthineers initiated a voluntary Class II recall for several models of its medical angiography X-ray machines. This action was reported by the Shanghai Municipal Drug Administration under the regulatory framework of the National Medical Products Administration (NMPA). The recall addresses a potential issue found in a small number of Artis machines, specifically those equipped with Siemens Tilt/Step (OR) examination beds and running software version VD11E. The main violation or issue centers on the safety limit switch, which was found to be in a default activated state prematurely, before the examination bed reached its destination. A malfunction in this switch could obstruct or restrict the examination bed's movement, causing the system to execute a safety stop. Should this occur, a field service engineer would be required to reactivate the system. Siemens Healthineers' required action is this voluntary recall to mitigate the identified safety risk. Detailed information regarding affected product models, specifications, and batches is provided in an associated "Medical Device Recall Event Report Form."

Company: https://www.globalkeysolutions.net/companies/siemens-healthineers-co-ltd/92a17b04-898c-4eba-81aa-91900b470181/