# China NMPA Product Recall - Stereo orientation system

Source: https://www.globalkeysolutions.net/records/china_product_recall/elekta-instrument-ab-sweden/c03327d3-820f-4a37-8f8d-8114ae0d833d/
Source feed: China

> China NMPA product recall for Stereo orientation system by Elekta Instrument AB (Sweden) published April 21, 2020. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) announced on April 21, 2020, a voluntary Class I

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Elekta Instrument AB initiates a recall of its stereo system.
- Company Name: Elekta Instrument AB (Sweden)
- Publication Date: 2020-04-21
- Product Name: Stereo orientation system
- Recall Level: Level 2 Recall
- Recall Reason: The issue concerns a product's storage rack not meeting standard manufacturing specifications, resulting in malfunction and potential clinical harm.
- Discovering Company: Elekta (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Elekta Instrument AB (Sweden)
- Summary: The National Medical Products Administration (NMPA) announced on April 21, 2020, a voluntary Class II recall by Elekta Instrument AB concerning its stereotactic system (Registration Certificate No.: 20193010531). The recall was initiated following a report from Elekta (Shanghai) Medical Device Co., Ltd., which identified a critical defect: the product's support frame did not meet standard specifications. This non-conformance resulted in improper device functionality and posed a potential risk of clinical harm to patients. Elekta Instrument AB is proactively recalling the affected systems to address this issue and ensure patient safety. Detailed information regarding specific models, specifications, and batch numbers is provided in the "Medical Device Recall List" and an accompanying "Medical Device Recall Event Report Form." The document does not specify any inspection dates, focusing on the company-initiated recall under NMPA's regulatory framework.

Company: https://www.globalkeysolutions.net/companies/elekta-instrument-ab-sweden/f5c6227c-7b5f-4699-836f-6d475c5d27ab/