# China NMPA Product Recall - Afterloader HDR Brachytherapy Afterloader

Source: https://www.globalkeysolutions.net/records/china_product_recall/varian-medical-systems-inc/b5036466-668c-4e21-bc67-874a56a84cc7/
Source feed: China

> China NMPA product recall for Afterloader HDR Brachytherapy Afterloader by Varian Medical Systems, Inc. published July 30, 2019. Recall level: Level 2 Recall. Varian Medical Systems, through its subsidiary Varian Medical Devices (China) Co., Ltd., has initiat

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Varian Medical Systems is voluntarily recalling the aftermarket HDR Brachytherapy Afterloader.
- Company Name: Varian Medical Systems, Inc.
- Publication Date: 2019-07-30
- Product Name: Afterloader HDR Brachytherapy Afterloader
- Recall Level: Level 2 Recall
- Recall Reason: Problem of broken trocar tip
- Discovering Company: Varian Medical Equipment (China) Co., Ltd.
- Manufacturing Company: Varian Medical Systems, Inc.
- Summary: Varian Medical Systems, through its subsidiary Varian Medical Devices (China) Co., Ltd., has initiated a voluntary Class II recall of its HDR Brachytherapy Afterloader. This action, reported on July 30, 2019, to the National Medical Products Administration (NMPA), addresses a critical product issue: the breaking of the trocar tip within the device. The HDR Brachytherapy Afterloader, identified by National Medical Device Registration Certificate No. 20173331129, is a specialized medical device utilized in cancer treatment. The identified defect with the trocar tip necessitates immediate attention to safeguard patient safety and ensure product integrity. The NMPA classified this as a Class II recall, indicating that the defect could potentially lead to temporary or medically reversible adverse health consequences, or that the likelihood of serious adverse health consequences is remote. As a required action, Varian Medical Systems voluntarily removed the affected devices from the market. Comprehensive details regarding the specific models, specifications, and batch numbers subject to this recall are provided in the accompanying "Medical Device Recall Event Report Form" attachment. This proactive measure by Varian aims to mitigate risks and maintain compliance with established medical device safety standards.

Company: https://www.globalkeysolutions.net/companies/varian-medical-systems-inc/ecd1e48f-3c7e-48c1-a3d3-a4c6add7e12d/