# China NMPA Product Recall - Brachytherapy planning software

Source: https://www.globalkeysolutions.net/records/china_product_recall/elekta-shanghai-medical-devices-co-ltd/cfff5589-b9ab-4575-b65d-4e4e8af40c57/
Source feed: China

> China NMPA product recall for Brachytherapy planning software by Elekta (Shanghai) Medical Devices Co., Ltd. published October 22, 2021. Recall level: Level 3 Recall. Elekta (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class III recall of its radiothera

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Elekta (Shanghai) Medical Devices Co., Ltd. has initiated a voluntary recall of its radiotherapy planning system software.
- Company Name: Elekta (Shanghai) Medical Devices Co., Ltd.
- Publication Date: 2021-10-22
- Product Name: Brachytherapy planning software
- Recall Level: Level 3 Recall
- Recall Reason: When brachytherapy planning software is used in two rare scenarios, it may cause the applicator model to mirror.
- Discovering Company: Elekta (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Elekta (Shanghai) Medical Devices Co., Ltd.
- Summary: Elekta (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class III recall of its radiotherapy planning software, as reported by the National Medical Products Administration (NMPA) on October 22, 2021. The recall stems from a critical software issue where the radiotherapy planning software may cause "applicator model mirroring" when utilized under two specific, rare usage conditions. This defect has the potential to impact the accuracy and safety of treatment planning. The regulatory framework governing this action is overseen by the NMPA, which reported the company's self-initiated recall. While no direct inspection dates are cited, the company proactively reported the issue and commenced the recall process. Elekta (Shanghai) Medical Devices Co., Ltd. is responsible for taking the required actions, which involve the comprehensive recall of affected software units. Detailed information regarding the specific product models, specifications, and batches subject to this recall is available in the "Medical Device Recall Event Report Form" provided by the company, ensuring all necessary corrective measures are implemented to address the identified software anomaly.

Company: https://www.globalkeysolutions.net/companies/elekta-shanghai-medical-devices-co-ltd/50382c65-250e-4fb4-9df9-cf88c8273214/